Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.
A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available. Information about the PDF Reader is available.
PMA Original Approvals
| P040048 6/28/06 |
Trilogy AB Acetabular System | Zimmer, Inc. Warsaw , IN 46581 |
Approval for the Trilogy AB Acetabular System. The device is indicated for either cemented or noncemented use in skeletally mature individuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis. |
| P050017 6/26/06 |
Zilver® Vascular Stent | Cook, Inc. Bloomington , IN 47402 |
Approval for the Zilver ® Vascular Stent. This device is indicated for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic vascular disease of the iliac arteries up to 100 mm in length, with a reference vessel diameter of 5 to 9 mm. Patients must be suitable for PTA and stent treatment. |
| P050042 6/7/06 |
ARCHITECT® Anti-HCV; ARCHITECT Anti-HCV Calibrator; ARCHITECT Anti-HCV Control | Abbott Laboratories Diagnostics Division Abbott Park , IL 60064 |
Approval for the Abbott ARCHITECT® Anti-HCV. This device is indicated for: The ARCHITECT® Anti-HCV Assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to hepatitis C virus (anti-HCV) in human adult serum and plasma (potassium EDTA, lithium heparin, and sodium heparin). Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with HCV (state of infection or associated disease not determined) in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The ARCHITECT® Anti-HCV Calibrator is used for the calibration of the ARCHITECT i System when the system is used for the qualitative detection of immunoglobulin G (IgG) and immunoglobulin M (igM) antibodies to hepatitis C virus (anti-HCV) in human adult serum and plasma (potassium EDTA, lithium heparin, and sodium heparin). The ARCHITECT® Anti-HCV Calibrator has been validated for use only on the ARCHITECT i System with the ARCHITECT® Anti-HCV Reagent Kit. Refer to the ARCHITECT® Anti-HCV assay reagent package insert for the full listing of information regarding the assay. The ARCHITECT® Anti-HCV Controls are used to provide an estimation of test precision and to detect systematic analytical deviations of the ARCHITECT i System (reagents, calibrator, and instrument (when the system is used for the qualitative detection of immunoglobulin G (IgG) and immunoglobulin M (igM) antibodies to hepatitis C virus (anti-HCV) in human adult serum and plasma (potassium EDTA, lithium heparin, and sodium heparin). The ARCHITECT® Anti-HCV Controls have been validated for use only on the ARCHITECT i System with the ARCHITECT® Anti-HCV Reagent Kit. |
| P050044 6/16/06 |
Vitagel™ Surgical Hemostat | Orthovita, Inc. Malvern , PA 19355 |
Approval for the Vitagel™ Surgical Hemostat. The device is indicated for use in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. |
| P050047 6/2/06 |
Juvéderm 24HV, Juvéderm 30 and Juvéderm 30HV Gel Implants | Inamed Corporation Santa Barbara , CA 93111 |
Approval for the Juvéderm 24HV, Juvéderm 30 and Juvéderm 30HV Gel Implants. The device is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). |
| P050049 6/1/06 |
Abbott AxSYM® HBsAg Assay | Abbott Laboratories Abbott Park , IL 60064 |
Approval for the Abbott AxSYM HBsAg Assay, which is indicated for: AxSYM® HBsAg: AxSYM® HBsAg is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of hepatitis B surface antigen (HBsAg) in neonatal serum, and adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes). The assay is used as an aid in the diagnosis of acute or chronic hepatitis B virus (HBV) infection in conjunction with other laboratory results and clinical information. The assay may be used to test for HBV infection in pregnant women. AxSYM® HBsAg Confirmatory: AxSYM® HBsAg Confirmatory in s microparticle enzyme immunoassay (MEIA) intended for the confirmation of the presence of hepatitis B surface antigen (HBsAg) in neonatal serum, and adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes). The assay is used for confirmation of samples found to be repeatedly reactive by the AxSYM HBsAg assay. The assay may be used to confirm hepatitis B virus (HBV) infection in pregnant woman. AxSYM® HBsAg Controls: The AxSYM® HBsAg Positive and Negative Controls are for use in monitoring the performance of the AxSYM HBsAg Reagent Kit and the AxSYM HBsAg Confirmatory Kit. The performance of the AxSYM HBsAg Controls have not been established with any other HBsAg assays. |
| P050051 6/1/06 |
ARCHITECT® AUSAB® Reagent Kit, ARCHITECT® AUSAB® Calibrators and ARCHITECT® AUSAB® Controls | Abbott Laboratories Abbott Park , IL 60064 |
Approval for the ARCHITECT® AUSAB® Reagent Kit, which is indicated for: ARCHITECT® AUSAB® Reagent Kit: The ARCHITECT AUSAB assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of antibody to hepatitis B surface antigen (anti-HBs) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum. It is intended for quantitative measurement of antibody response following hepatitis B virus (HBV) vaccination, determination of HBV immune status, and for the laboratory diagnosis of HBV disease associated with HBV infection when used in conjunction with other laboratory results and clinical information. ARCHITECT® AUSAB® Calibrators: The ARCHITECT AUSAB Calibrators are used to calibrate the ARCHITECT i System when the system is used for the quantitative determination of antibody to hepatitis B surface antigen (anti-HBs) using the ARCHITECT AUSAB Reagent Kit. The performance of the ARCHITECT AUSAB Calibrators has not been established with any other anti- HBs assays. ARCHITECT® AUSAB® Controls: The ARCHITECT AUSAB Controls are used for monitoring the performance of the ARCHITECT i System when used for the quantitative determination of antibody to hepatitis B surface antigen (anti-HBs) using the ARCHITECT AUSAB Reagent Kit. The performance of the ARCHITECT AUSAB Controls has not been established with any other anti-HBs Assays. |
PMA Supplemental Approvals
| P800036/S036 6/23/06 180-Day |
INFUSAID Model 400 Implantable Infusion Pumps and Accessories | Codman & Shurleff, Inc. Raynham , MA 02767 |
Approval for a manufacturing site at Codman & Shurtleff, Inc. Raynham , Massachusetts . |
| P850020/S022 6/22/06 Special |
PROSORBA® Column | Fresenius Medical Care Lexington , MA 02420 |
Approval for a labeling change to include information on the use of the Haemonetics MCS and Haemonetics MCS+ plasmapheresis systems in conjunction with the PROSORBA® Column. |
| P860004/S084 6/9/06 Special |
Medtronic SynchroMed Infusion System | Medtronic Neurological Minneapolis , MN 55432 |
Approval for an update to the Model 8840 N Vision Programmer Guide regarding the repositioning and repeating of an existing warning. |
| P900009/S022 6/26/06 180-Day |
Exogen 4000+ Bone Healing System | Smith & Nephew, Inc. Memphis , TN 38116 |
Approval for the modification of the existing Exogen 2000+ and Exogen 3000 low intensity ultrasound fracture treatment systems – Sonic Accelerated Fracture Healing System (SAFHS®) to the Exogen 4000+. The Exogen 4000+ is modified to incorporate user-interface modifications and design modifications to compensate for changes in electronic component availability. The device, as modified, will be marketed under the trade name Exogen 4000+ Bone Healing System. The Exogen 4000+ is indicated for the non-invasive treatment of established non-unions excluding skull and vertebra. In addition, it is indicated for accelerating the time to a healed fracture, for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopaedically managed by closed reduction and cast immobilization. |
| P900009/S023 6/30/06 Real-Time |
Exogen 2000+ Bone Healing System | Smith & Nephew, Inc., Orthopaedics Division Memphis , TN 38116 |
Approval for the incorporation of a Dri-Shield 2000 Moisture Barrier Bag (Electrostatic Discharge [ESD] bag) as part of the device packaging. |
| P910023/S099 6/26/06 135-Day |
Photon Micro, Epic™, Atlas®, Epic+™, and Atlas+® Families of Implantable Cardioverter Defibrillators (ICDs) | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for changes to the automated test software (ATE) used for component and subassembly level testing during the manufacturing process. |
| P910023/S109 6/20/06 Real-Time |
Modifications to the STJ Housecall Plus System | St. Jude Medical CRMD Sunnyvale , CA 94086 |
Approval for the enhancements to the data processing used for the St. Jude Medical Housecall Plus System. |
| P910077/S062 6/23/06 Special |
Model 6482 Communicator Latitude Patient Management System | Guidant Corporation St. Paul , MN 55112 |
Approval to modify the instructions for the Latitude Clinician Manual. |
| P940031/S044 6/28/06 135-Day |
DISCOVERY, MERIDIAN | Guidant Corporation St. Paul , MN 55112 |
Approval for the addition of inspection criteria to allow for solder balls under components on the hybrid. |
| P950020/S017 6/30/06 Special |
Flextome Cutting Balloon™ Monorail (MR)/Over-the-Wire (OTW) & Cutting Balloon Ultra 2™ Microsurgical Dilatation Device Monorail | Boston Scientific IVG San Diego , CA 92123 |
Approval for changes to the Directions of Use (DFU) manual. |
| P960013/S014 6/8/06 135-Day |
SDX Permanent Pacemakers | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for the reduction in the humidity oven cure-time for SJM leads. |
| P960013/S018 6/6/06 Real-Time |
Tendril ST Lead Models 1888TC and 1882TC | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval to modify the lead insulation on the Tendril ST 1788T/TC and Tendril ST 1782 leads, and to reduce the outer coil wire diameter on the Tendril ST 1782 lead. The devices, as modified, will be marketed under the trade names Tendril ST Lead Model 1888TC and Tendril ST Lead Model 1882TC. The Tendril ST Lead Model 1888TC is indicated for permanent sensing and pacing in either the right atrium or the right ventricle, in combination with a compatible pulse generator. The tendril ST Lead Model 1882TC is indicated for permanent sensing and pacing in either the right atrium or the right ventricle, in combination with a compatible pulse generator. |
| P960040/S128 6/22/06 Special |
VITALITY HE | Guidant Corporation St. Paul , MN 55112 |
Approval to add warning regarding correct device implant orientation. |
| D970003/S049 6/28/06 135-Day |
DISCOVERY, INSIGNIA, PULSAR, NEXUS, INTELIS, VIRTUS Plus | Guidant Corporation St. Paul , MN 55112 |
Approval for the addition of inspection criteria to allow for solder balls under components on the hybrid. |
| P970003/S063 6/29/06 Real-Time |
VNS Therapy™ System | Cyberonics, Inc. Houston , TX 77058 |
Approval for labeling harmonization and modularization for physician, pulse generator, lead and patient kit labeling. |
| P970003/S066 6/8/06 Real-Time |
VNS Therapy System | Cyberonics, Inc. Houston , TX 77058 |
Approval for modifications to the Model 250 Programming Software Version 7.1. |
| D970003/S071 6/12/06 Special |
INSIGNIA I Family of Devices | Guidant Corporation St. Paul , MN 55112 |
Approval for the following additions/ modification s to the label: 1) Add the following test to add information regarding the potential for interaction between the pacemaker and some hospital monitoring and diagnostic equipment: “Electrical signals introduced into the body by some hospital monitoring and/or diagnostic equipment may result in accelerated pacing, possibly up to the maximum sensor-driven rate, when MV is programmed On. Examples of this equipment include, but are not limited to, respiratory monitors, diagnostic echo imaging, surface ECG monitors, and hemodynamic monitors. Deactivate the MV sensor when interaction with this equipment is suspected.” 2) Add additional information regarding how to proceed if the device is exposed to low and extremely low temperatures. 3) Add a “Caution:” regarding the effect of not using a lead or a lead port plug. 4) Add a “Caution:” to the Entra label regarding the implantation of a replacement device into a pocket that previously housed a larger device. 5) Add a note in the patient counseling section that the devices are subject to failure. |
| P970004/S033 6/30/06 180-Day |
Medtronic InterStim® Sacral Nerve Stimulation (SNS)™ System | Medtronic, Inc. Shoreview , MN 55126 |
Approval for modifications to the InterStim® neurostimulator (Model 3058 InterStim® II), patient programmer (Model 3037 iCon), therapy application software, tined leads (Models 3889/3093), system accessories (Model 37092 External Antenna, torque hex wrench, tunneling tool), and labeling architecture. |
| P970004/S039 6/27/06 Real-Time |
Medtronic InterStim Therapy for Urinary Control | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for software changes to the Model 8840 N’Vision Programming System. |
| P970051/S038 6/14/06 Real-Time |
Nucleus 24 Cochlear Implant System | Cochlear Americas Englewood , CO 80112 |
Approval for 1) Version 1.3 of the Custom Sound programming software which includes software modifications and enhancements which will enable recipients of the previous generation Nucleus 24 cochlear implants to use the latest approved Freedom speech processor, and 2) Freedom processor firmware changes related to the processor’s liquid-crystal display (LCD). |
| P970058/S022 6/23/06 180-Day |
ImageChecker M5000 D, ImageChecker M5000 DM, ImageChecker M5000 LX, ImageChecker M5000 DX Version 8.0 | R2 Technology, Inc. Sunnyvale , CA 94087 |
Approval of new labeling that will present the specificity of CAD marks generated by R2 ImageChecker Computer Aided Detection System as well as its ability to mark actionable priors. The indications for use remain as previously approved: The ImageChecker M5000 is a computer system intended to identify and mark regions of interest on routine screening mammograms to bring them to the attention of the radiologist after the initial reading has been completed. Thus, the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review. |
| P980022/S017 6/14/06 Real-Time |
Guardian REAL-Time Continuous Glucose Monitoring System | Medtronic MiniMed Northridge , CA 91325 |
Approval for modifications to the monitor and transmitter of the previously approved Guardian RT System. The REAL-Time monitor has a larger LCD for ease of viewing for the user and to support graphical display of the data. Also, in the REAL-Time monitor, RF communication is received from the transmitter at 916.35 MHz, which is the identical frequency used in the Paradigm Model MMT-515/715 insulin pumps (cleared under K040676). In addition, the meter readings for calibration can be manually entered, identical to the Guardian RT, or automatically, via telemetry, when using the Paradigm Link meter in the identical scheme as in the previously cleared insulin pump. The calibration algorithm and glucose values reported by the system are identical between the Guardian RT System and the Guardian REAL-Time System. The device, as modified, will be marketed under the trade name Guardian REAL-Time Continuous Glucose Monitoring System and is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (ages 18 and older) with diabetes mellitus, for the purpose of improving diabetes management. It alerts if a glucose level falls below or rises above, preset values. Values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose meter and not on Guardian REAL-Time CGM System values. The Guardian REAL-Time CGM System provides real-time glucose values that allow users to track patterns in glucose concentrations and to possibly identify episodes of low and high blood glucose. It also stores the data so that it can be analyzed to track patterns. Glucose data can be further downloaded to PC software for analysis of historical values. |
| P980043/S009 6/5/06 Real-Time |
Hancock® II Porcine Bioprostheses Models T505 and T510 | Medtronic Heart Valves Santa Ana , CA 92705 |
Approval for modifications to: 1) the jar retainer used for both the mitral aortic configurations of Hancock® II Bioprostheses; 2) the serial number tag for mitral and aortic configurations of the Hancock® II Bioprostheses; 3) the valve holder for the Hanckck® II Mitral Bioprotheses; and 4) the “Instructions for Use” to accommodate the changes in the retainer, tag and mitral holder. |
| P990033/S007 6/6/06 Special |
PepGen P-15 Dental Bone Grafting Material | Dentsply International York , PA 17405 |
Approval for the change in Indication for Use – the device is no longer intended for reuse after resterilization and will be labeled as a single use only device. |
| P990040/S004 6/1/06 Special |
TRUFILL® n-Butyl Cyanoacrylate (nBCA) Liquid Embolic System | Cordis Neurovascular Miami Lakes , FL 33014 |
Approval for revisions to the product label regarding use of the product under high flow conditions, and with ratios of contrast reagent and nBCA outside of those ratios tested in the clinical study. |
| P990064/S014 6/5/06 Real-Time |
MOSAIC® Porcine Bioprosthesis, Models 305, 310 | Medtronic Heart Valves Santa Ana , CA 92705 |
Approval for modifications to: 1) the jar retainer used for both the mitral and aortic configurations of the Mosaic® Bioprostheses; 2) the serial number tag for mitral and aortic configurations of the Mosaic® Bioprostheses; 3) the valve holder for the Mosaic® Mitral Bioprostheses, and 4) the “Instructions for Use”: to accommodate the changes in the retainer, tag and mitral holder. |
| P000010/S007 6/22/06 Real-Time |
AMPLICOR HCV Test, v2.0 | Roche Molecular Systems, Inc. Pleasanton , CA 94566 |
Approval for the extension of the shelf life to 24 months of the HCV Master Mix, version 2,.0, a component of the AMPLICOR HCV Test, v2.0. The device, as modified, will be marketed under the trade name AMPLICOR HCV Test, v2.0 and is indicated for the qualitative detection of HCV RNA inhuman serum or plasma from blood collected in EDTA (EDTA plasma). The test detects by reverse transcribing target HCV RNA in complimentary DNA (cDNA), amplifying cDNA by polymerase chain reaction (PCR), hybridizing amplified cDNA with an oligonucleotide probe that binds enzyme, and catalyzing conversion of substrate to a colored product that is recognized by a microwell plate reader. The AMPLICOR HCV Test, v2.0 is indicated for patients who have evidence of liver disease and antibody evidence of HCV infection, and who are suspected to be actively infected with HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active HCV infection |
| P000012/S009 6/16/06 Real-Time |
COBAS AMPLICOR HCV Test, v2.0 | Roche Molecular Systems, Inc. Pleasanton , CA 94566 |
Approval for the extension of the shelf life to 24 months of the HCV Master Mix, version 2.0, a component of the COBAS AMPLICOR HCV Test, v2.0. The device, as modified, will be marketed under the trade name COBAS AMPLICOR HCV Test, v2.0 and is indicated for the qualitative detection of HCV RNA in human serum or plasma from blood collected in EDTA (EDTA plasma). The test detects by reverse transcribing target HCV RNA in complimentary DNA (cDNA), amplifying cDNA by polymerase chain reaction (PCR), hybridizing amplified cDNA with an oligonucleotide probe that binds enzyme, and catalyzing conversion of substrate to a colored product that is recognized by the COBAS AMPLICOR™ Analyzer. The COBAS AMPLICOR HCV Test, v2.0 is indicated for patients who have evidence of liver disease and antibody evidence of HCV infection, and who are suspected o be actively infected with HCV. |
| P000018/S042 6/16/06 180-Day |
Beta-Cath System | Best Vascular, Inc. Norcross , GA 30093 |
Approval for modifications to the Beta-Cath System labeling, specifically the incorporation of the START/START 40/20 5-year post-approval study results in the Beta-Cath Instructions for Use. |
| P000037/S008 6/23/06 180-Day |
On-X® Prosthetic Heart Valve | MCRI Austin , TX 78754 |
Approval for a manufacturing site in Austin, Texas. |
| P000040/S008 6/23/06 Real-Time |
HTA™ System |
Boston Scientific Corporation Marlborough , MA 01752 |
Approval for 1) Addition of the Linear Flash Card Memory to the Central Processing Board; 2) Temperature Controller PID Settings/Increase in Cycle Time programmed into Heater Logic and Controller Board; and 3) Addition of Components to the Level Sensor Board. |
| P010012/S109 6/28/06 135-Day |
CONTAK CD/ EASYTRAK | Guidant Corporation St. Paul , MN 55112 |
Approval for the addition of in-line LAL testing (pyrogenicity testing) to the inspection procedure for each incoming lot received at Guidant for the Universal Finishing Wire® accessories. |
| P010012/S118 6/23/06 Real-Time |
EASYTRAK 2 LV-1 and EASYTRAK 2 IS-1 Physician Manuals | Guidant Corporation St. Paul, MN 55112 |
Approval for modifications to the Instructions for Use and Warnings as part of the physician Manuals. |
| P010012/S132 6/22/06 Special |
CONTAK RENEWAL 3 | Guidant Corporation St. Paul , MN 55112 |
Approval to add warning regarding correct device implant orientation. |
| P010013/S015 6/16/06 180-Day |
NovaSure Impendence Controlled Endometrial Ablation System | Cytyc Surgical Products Mountain View , CA 94041 |
Approval for a manufacturing site located at Cytyc Surgical Products, Mountain View, California. |
| P010015/S020 6/28/06 180-Day |
InSync CRT-P Registry | Medtronic, Inc. CRM Shoreview , MN 55126 |
Approval for modifications to the post-approval study for the device. |
| P010031/S043 6/30/06 Real-Time |
Medtronic InSync Maximo/ InSync Sentry Devices |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the Model 9998 v2.2 Software for use on the Model 2090 Programmers. |
| P010051/S004 6/16/06 Real-Time |
IMMULITE®/ IMMULITE® 1000 and IMMULITE® 2000 Anti-HBc Assays | Diagnostic Products Corporation Los Angeles , CA 90045 |
Approval for revision of the analytical sensitivity claim for the IMMULITE®/ IMMULITE® 1000 and IMMULITE® 2000 Anti-HBc Assays. |
| P010054/S004 6/30/06 Real-Time |
Elecsys Anti-HBs Immunoassay and Elecsys PreciControl Anti-HBs | Roche Diagnostics Indianapolis , IN 46250 |
Approval for a modification to the standardization process for the Elecsys Anti-HBs Immunoassay and Elecsys PreciControl Anti-HBs assay for use on the Elecsys 2010 analyzer. The device, as modified, will be marketed under the trade name Elecsys Anti-HBs Immunoassay and Elecsys PreciControl Anti-HBs and is indicated for the qualitative detection in human serum and plasma. |
| P020018/S009 6/1/06 Special |
Zenith® FLEX™ AAA Endovascular Graft with the H&LB One-Shot™ Introduction System | Cook, Inc. Bloomington , IN 47402 |
Approval for modifications to the Zenith® FLEX™ AAA Endovascular Graft Ancillary Component labeling to clarify the length limitations for use of the 58 mm length main body extension when used in conjunction with the shortest Zenith® Main Body components. |
| P020045/S016 6/29/06 Real-Time |
CCT.2 CryoAblation Console System | CryoCath Technologies, Inc. Brookline , MA 02445 |
Approval for modifications to the patient board IC of the CCT.2 CryoAblation Console. |
| P020050/S003 6/16/06 180-Day |
WaveLight ALLEGRETTO WAVE EYE-Q Excimer Laser System | SurgiVision® Regulatory Consultants, LLC North Reading , MA 01864 |
Approval for a change in repetition rate from 200 Hz to 400 Hz. The device, as modified, will be marketed under the trade name ALLEGRETTO WAVE EYE-Q Excimer Laser System and is indicated for laser assisted in situ keratomileusis (LASIK) in patients who are 18 years of age or older: 1) for the reduction or elimination of myopia of up to -12.0 diopters (D) of sphere and up to -6.0 D of astigmatism at the spectacle plane in patients with documentation of a stable manifest refraction defined as ≤0.50 D of preoperative spherical equivalent shift over one year prior to surgery; and 2) for the reduction or elimination of hyperopic refractive errors up to +6.0 D of sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D in patients with documentation of a stable manifest refraction defined as ≤0.50 D of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia. |
| P030005/S019 6/28/06 135-Day |
CONTAK RENEWAL TR2 | Guidant Corporation St. Paul , MN 55112 |
Approval for the addition of inspection criteria to allow for solder balls under components on the hybrid. |
| P030008/S003 6/16/06 180-Day |
WaveLight ALLEGRETTO WAVE EYE-Q Excimer Laser System | SurgiVision® Regulatory Consultants, LLC North Reading , MA 01864 |
Approval for a change in repetition rate from 200 Hz to 400 Hz. The device, as modified, will be marketed under the trade name ALLEGRETTO WAVE EYE-Q Excimer Laser System and is indicated for laser assisted in situ keratomileusis (LASIK) in patients who are 18 years of age or older: 1) for the reduction or elimination of myopia of up to -12.0 diopters (D) of sphere and up to -6.0 D of astigmatism at the spectacle plane in patients with documentation of a stable manifest refraction defined as ≤0.50 D of preoperative spherical equivalent shift over one year prior to surgery; and 2) for the reduction or elimination of hyperopic refractive errors up to +6.0 D of sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D in patients with documentation of a stable manifest refraction defined as ≤0.50 D of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia. |
| P030022/S002 6/16/06 135-Day |
Reflection Ceramic Acetabular System | Smith & Nephew, Inc. Memphis , TN 38116 |
Approval for manufacturing process changes to be made by CeramTec, Inc., for the Biolox® forte ceramic femoral heads and inserts. |
| P030027/S002 6/23/06 Real-Time |
Ceramic TRANSCEND® Articulation System | Wright Medical Technology, Inc. Arlington , TN 38002 |
Approval for the addition of an intermediate ceramic liner size (36/48G); three replacement 36mm OD ceramic heads with consistent offset (-3.5 mm, 0 mm, and +3.5 mm); and femoral stems and acetabular shells as specified in submissions received March 8, 2006 and June 21, 2006 which have been round substantially equivalent via the 510(k) process. The device, as modified, will be marketed under the trade name Ceramic LINEAGE®/ TRANSCEND® Articulation System and is indicated for use in primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis. |
| P040012/S015 6/26/06 135-Day |
Acculink® and RX Acculink® Carotid Stent System | Abbott Vascular, Vascular Solutions Santa Clara , CA 95054 |
Approval for a modification to the Lot History Bill of Materials to remove specified quality audits that are not necessary or value added. |
| P040028/S002 6/26/06 Special |
LUMA Cervical Imaging System | MediSpectra, Inc. Lexington , MA 02421 |
Approval for two additional integrity verification tests. |
| P040038/S004 6/30/06 Special |
Xact® Carotid Stent System | Abbott Vascular Devices Redwood City , CA 94063 |
Approval for modifications to the labeling and device inspection processes. |
| P040042/S002 6/27/06 Real-Time |
Therapy Dual 8 IBI-1500T6 Cardiac Ablation Generator | Irvine Biomedical, Inc. Irvine , CA 92614 |
Approval for a software modification that allows the elimination of a minor delay in graphical recording and displaying time. |
| P040043/S010 6/16/06 Special |
Gore TAG Thoracic Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 |
Approval for modifications to the procedures employed in the labeling of the Gore TAG Thoracic Endoprosthesis. These modifications are intended to enhance the safe use of the device by minimizing the potential for mislabeling of devices. |
30-Day Notices (135 Day Supplement was not required)
| P840064/S031 6/16/06 |
Viscoat®, Duovisc® and DisCoVisc® Ophthalmic Viscosurgical Device | Alcon Research, Ltd. Fort Worth , TX 76134 |
Change in sterilization process parameters. |
| P860019/S209 6/8/06 |
PTCA/Perfusion Catheters | Boston Scientific Corporation, Cardiovascular Maple Grove , MN 55311 |
Addition of an alternative biological indicator (BI). |
| P860019/S210 6/8/06 |
Quantum Maverick PTCA Balloon Catheter | Boston Scientific Corporation, Maple Grove , MN 55311 |
Change the inspection criteria for the creases located in the proximal balloon bond. |
| P860019/S211 6/23/06 |
Maverick Family of PTCA Balloon Catheters and Maverick Over-the-Wire (OTW) and Maverick 2 Monorail (MR) | Boston Scientific Corporation, Maple Grove , MN 55311 |
Removal of a redundant in-process inspection for balloon bunching for select sizes of Maverick OTW and Maverick 2 MR PTCA catheters. |
| P880003/S088 6/16/06 |
PTCA Balloon Dilatation Catheters | Cordis Corporation Miami Lakes , FL 33014 |
Change in a “joining” process where a different solvent or energy source is used to join the catheter inner and outer bodies to the hubs. |
| P880086/S121 6/8/06 |
Solus, Addvent, Solus II, Synchrony, Phoenix III, Trilogy, Affinity, Integrity, Entity, Identity, Verity, Victory Pacemakers | St. Jude Medical Sunnyvale , CA 94086 |
Change from a manual to an automated process to remove hydrohone beads and air dry the pacemakers following this hydrohoning process, which will be performed using the Cyclone wash-dry machine. |
| P890047/S018 6/16/06 |
Provisc® Ophthalmic Viscosurgical Device | Alcon Research, Ltd. Fort Worth , TX 76134 |
Change in sterilization process parameters. |
| P900056/S088 6/8/06 |
Rotoblator Rotational Angioplasty System Wire | Boston Scientific Corporation, Cardiovascular Maple Grove , MN 55311 |
Addition of an alternative biological indicator (BI). |
| P910023/S108 6/8/06 |
Implantable Cardioverter Defibrillator devices (ICDs and CRT-Ds) | St. Jude Medical CRMD Sunnyvale , CA 94086 |
Chip modifications and a yield improvement at the chip supplier. |
| P910023/S110 6/28/06 |
Implantable Cardioverter Defibrillators | St. Jude Medical CRMD Sunnyvale , CA 94086 |
Add a vendor for welded half-can components. |
| P920047/S034 6/13/06 |
Blazer RF Ablation Catheter | Boston Scientific Corporation San Jose , CA 95134 |
Addition of an alternate biological indicator (BI) supplier. |
| P930031/S025 6/8/06 |
Wallstent Tips Endoprosthesis | Boston Scientific Corporation, Cardiovascular Maple Grove , MN 55311 |
Addition of an alternative biological indicator (BI). |
| P930038/S047 6/26/06 |
Angio-Seal™ Vascular Closure Device | St. Jude Medical, Inc. Minnetonka , MN 55345 |
Alternative mold-gate process. |
| P940019/S020 6/8/06 |
Wallkstent Iliac Endoprosthesis | Boston Scientific Corporation, Cardiovascular Maple Grove , MN 55311 |
Addition of an alternative biological indicator (BI). |
| P950020/S016 6/8/06 |
Cutting Balloon | Boston Scientific Corporation, Cardiovascular Maple Grove , MN 55311 |
Addition of an alternative biological indicator (BI). |
| P960013/S019 6/13/06 |
Tendril ST Model 1788T/TC and 1782 Brachycardia Leads | St. Jude Medical CRMD Sylmar , CA 91342 |
Change to the inner crimp core material. |
| P960013/S020 6/26/06 |
Tendril® Leads | S. Jude Medical Sylmar, CA 91342 |
Changes to the inspection process for medical adhesive on the electrode ring during production of the leads. |
| P970003/S067 6/22/06 |
VNS Therapy Perennia Model 303 Lead | Cyberonics, Inc. Houston , TX 77058 |
Change to the joining process for the Lead Model 303. |
| D970003/S074 6/28/06 |
|
Guidant Corporation St. Paul , MN 55112 |
Changes to the integrated circuit level manufacturing test software. |
| D970003/S075 6/28/06 |
INSIGNIA/NEXUS Pulse Generators | Guidant Corporation St. Paul , MN 55112 |
Addition of an alternate supplier for the printed circuit board (PCB). |
| P980003/S017 6/13/06 |
Chilli Cooled Ablation System | Boston Scientific Corporation San Jose , CA 95134 |
Addition of an alternate biological indicator (BI) supplier. |
| P980033/S014 6/8/06 |
Wallstent Venous Endoprosthesis | Boston Scientific Corporation, Cardiovascular Maple Grove , MN 55311 |
Addition of an alternative biological indicator (BI). |
| P990054/S008 6/13/06 |
Chilli Cooled RPM Catheter | Boston Scientific Corporation San Jose , CA 95134 |
Addition of an alternate biological indicator (BI) supplier. |
| P000014/S014 6/5/06 |
VITROS Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Addition of a specification for raw material. |
| P000044/S012 6/5/06 |
VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator, and the VITROS Immunodiagnostic Products HBsAg Confirmatory Kit | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Addition of a specification for raw material. |
| P010012/S128 6/1/06 |
RENEWAL 3 RF CRT-Ds | Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Addition of a second supplier for the unfiltered feedthru used in the device. |
| P020009/S026 6/8/06 |
Express Coronary Stent System | Boston Scientific Corporation, Cardiovascular Maple Grove , MN 55311 |
Addition of an alternative biological indicator (BI). |
| P020009/S027 6/8/06 |
Express 2™ Coronary Stent System | Boston Scientific Corporation, Maple Grove , MN 55311 |
Change the inspection criteria for the creases located in the proximal balloon bond. |
| P020025/S017 6/13/06 |
Blazer XP RF Ablation Catheter | Boston Scientific Corporation San Jose , CA 95134 |
Addition of an alternate biological indicator (BI) supplier. |
| P020045/S019 6/13/06 |
Freezor® Cardiac CryoAblation Catheters, Freezor Xtra and Freezor MAX Cardiac CryoAblation Catheters | CryoCath Technologies, Inc. Brookline , MA 02445 |
Adhesive change. |
| P030004/S001 6/22/06 |
Onyx Liquid Embolic | Ev3 Neurovascular Irvine , CA 92618 |
Change in the manufacturing instructions to emphasize a continuous mixing process. |
| P030024/S005 6/5/06 |
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Addition of a specification for three different raw materials. |
| P030025/S031 6/8/06 |
TAXUS™ Express 2™ Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation, Cardiovascular Maple Grove , MN 55311 |
Addition of an alternative biological indicator (BI). |
| P030025/S032 6/8/06 |
TAXUS™ Express 2™ Paclitaxel Eluting Stent System | Boston Scientific Corporation, Maple Grove , MN 55311 |
Change the inspection criteria for the creases located in the proximal balloon bond. |
| P030026/S010 6/5/06 |
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Addition of a specification for a raw material. |
| P030035/S015 6/8/06 |
Frontier, and Frontier II Pacemakers | St. Jude Medical Sunnyvale , CA 94086 |
Change from a manual to an automated process to remove hydrohone beads and air dry the pacemakers following this hydrohoning process, which will be performed using the Cyclone wash-dry machine. |
| P030054/S029 6/8/06 |
Implantable Cardioverter Defibrillator devices (ICDs and CRT-Ds) | St. Jude Medical CRMD Sunnyvale , CA 94086 |
Chip modifications and a yield improvement at the chip supplier. |
| P040016/S010 6/8/06 |
Liberté Coronary Stent System | Boston Scientific Corporation, Cardiovascular Maple Grove , MN 55311 |
Addition of an alternative biological indicator (BI). |
| P040016/S011 6/8/06 |
Liberté™ Coronary Stent System | Boston Scientific Corporation, Maple Grove , MN 55311 |
Change the inspection criteria for the creases located in the proximal balloon bond. |
| P040024/S007 6/23/06 |
Restylane Injectable Gel | Medicis Scottsdale , AZ 85258 |
Changes to four internal processing functions. |
| P050009/S002 6/16/06 |
C 2a-Taper™ Acetabular System | Biomet Orthopedics, Inc. Warsaw , IN 46582 |
Replacement of the previous software system with an image analyzer software and the revision of the porous coating test procedures. |
Summary of PMA Originals & Supplements Approved
Originals: 7
Supplements: 49
Summary of PMA Originals Under Review
Total Under Review: 97
Total Active: 43
Total On Hold: 54
Number Greater Than 180 Days: 5
Summary of PMA Supplements Under Review
Total Under Review: 409
Total Active: 205
Total On Hold: 204
Number Greater Than 180 Days: 17
Summary of All PMA Submissions Received
Originals: 4
Supplements: 77
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 49
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 114.9
FDA Time: 85.4 Days MFR Time: 29.5 Days
Updated November 25, 2008
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