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
| P040033 5/9/06 |
Birmingham Hip Resurfacing (BHR) System | Smith & Nephew Orthopaedics | Approval for the Birmingham Hip Resurfacing (BHR) System. The BHR System is a single use device intended for hybrid fixation: cemented femoral head component and cementless acetabular component. The HGR System is intended for use in patients requiring primary hip resurfacing arthroplasty due to: 1) Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/ developmental dislocation of the hip (DDH), or 2) Inflammatory arthritis such as rheumatoid arthritis. The BHR System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring future ipsilateral hip joint revision. |
| P040051 5/12/06 |
Stelkast Surpass™ Acetabular System | PaxMed International San Diego, CA 92130 | Approval for the Stelkast Surpass™ Acetabular System. The device is indicated for cementless use in primary total hip arthroplasty in skeletally mature individuals with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis. |
PMA Supplemental Approvals
| P790017/S085 5/12/06 Special |
Medtronic Vascular NC Stormer MX2 Balloon Dilitation Catheter & Sprinter MX2 Balloon Dilitation Catheter | Medtronic Vascular, Inc. Santa Rosa, CA 95403 | Approval for updates to the instructions for use (IFU) in order to enhance the safety of the device and avoid the guidewire exiting the guide way of the catheter. |
| P810002/S059 5/11/06 Real-Time |
Aortic Standard Polyester Cuff, Model A-101; Mitral Standard Polyester Cuff, Model M-101; Aortic Expanded Polyester Cuff, Model AEC-102; Mitral Expanded Polyester Cuff, Model MEC-102; Aortic Standard PTFE Cuff, Model AT-103; Mitral Standard PTFE Cuff, Model MT-103; Aortic Expanded PTFE Cuff, Model AET-104; Mitral Expanded PTFE Cuff, Model MET-104; Aortic Hemodynamic Plus, Model AHP-105; Mitral Hemodynamic Plus, Model MHP-105; Masters Series Aortic Polyester Cuff, Model AJ-501; Masters Series Mitral Polyester Cuff, Model MJ-501; Masters Series Aortic Expanded Polyester Cuff, Model AECJ-502; Masters Series Mitral Expanded Polyester Cuff, Model MECJ-502; Masters Series Aortic PTFE Cuff, Model ATJ-503; Masters Series Mitral PTFE Cuff, Model MTJ-503; Masters Series Expanded PTFE Cuff, Aortic, Model AETJ-504; Masters Series Expanded PTFE Cuff, Mitral, Model METJ-504; Masters Series Aortic Hemodynamic Plus, Model AHPJ-505; Masters Series Mitral Hemodynamic Plus, Model MHPJ-505; Masters Series Aortic Expanded Hemodynamic Plus, Model AEHPJ-505; Masters Series Mitral Expanded Hemodynamic Plus, Model MEHPJ-505; Masters Series Aortic Hemodynamic Plus with FlexCuff, Model AFHPJ-505; Masters Series Aortic Valved Graft, Model CAVGJ-514; Masters Series Aortic Valved Graft, Model CAVGJ-514 00; Masters HP Valved Graft, Model VAVGJ-515 | St. Jude Medical St. Paul, MN 55117 | Approval for changes to the Physician’s Manual (IFU) and Patient ID Card for the above listed models. |
| P820003/S076 5/12/06 180-Day |
Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models. |
| P850020/S023 5/11/06 Special |
PROSORBA® Column | Fresenius Medical Care Lexington, MA 02420 | Approval for a labeling change to include information on the use of the Cobe® Spectra Apheresis System and the Fresenius™ AS104 system in conjunction with the PROSORBA® Column. |
| P850048/S020 5/18/06 Real-Time |
Access® Hybritech® PSA Reagents on the Access® Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the Access PSA reagents for use on the UniCel® DxC 600i Synchron® Access® Clinical System. The device, as modified, will be marketed under the trade name Access® PSA Reagent on the Access® Immunoassay System. |
| P850051/S061 5/12/06 180-Day |
Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models. |
| P860022/S056 5/30/06 135-Day |
Boston EQUALENS® (itafluorofocon A and oprifocon A) | Bausch & Lomb, Inc. Rochester, NY 14609 | Approval for the addition of a cold oxygen plasma treatment step to the current manufacturing process for the Boston EQUALENS (itafluorofocon A), Boston EQUALENS II, and Boston Orthokeratology (oprifocon A) Shaping Lens. |
| P860057/S033 5/18/06 Real-Time |
Carpentier-Edwards® PERIMOUNT Plus® Mitral Pericardial Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 | Approval for a cloth folding modification to the sewing ring. |
| P880086/S112 5/2/06 135-Day |
St. Jude Medical Implantable Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for a test being added to the IC wafer probe test suite. |
| P890003/S097 5/12/06 180-Day |
Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models. |
| P890003/S103 5/8/06 Real-Time |
2490G CareLink Monitor Model 2491 DDMA Software | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the addition of the support for the InSync III Marquis to the 2490G CareLink Monitor and the 2491 Device Data Management Application (DDMA) software, and the updates to the firmware used in the 2490G CareLink Monitor and updates to the 2491 DDMA software. |
| P900061/S060 5/12/06 180-Day |
Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models. |
| P900061/S064 5/8/06 Real-Time |
GEM® Model 7227 | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the addition of the support for the InSync III Marquis to the 2490G CareLink Monitor and the 2491 Device Data Management Application (DDMA) software, and the updates to the firmware used in the 2490G CareLink Monitor and updates to the 2491 DDMA software. |
| P910023/S081 5/11/06 Real-Time |
Convert™ (Model V-191) and Convert+ (Model V-195) Systems with Application Software Model 3307 Version 4.9 | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for the Convert™ and Convert+ ICD systems with the application software Model 3307 version 4.9. The device, as modified, will be marketed under the trade name Convert™ and Convert+ ICD systems and is indicated to provide ventricular antitachycardia pacing (Model V-195 only) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. |
| P910077/S056 5/1/06 135-Day |
VENTAK MINI II+ HE, MINI IV, MINI IV+ Pulse Generators | Guidant Corporation St. Paul, MN 55112 | Approval for an update the visual inspection criteria in GMAI (General Manufacturing Area Instruction) I00093. |
| P930016/S024 5/3/06 Real-Time |
VISX STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS™) and WaveScan WaveFront® System | Advanced Medical Optics, Inc. Santa Clara, CA 95051 | Approval for Wavescan® System Software Version 3.70 containing minor design (user interface and streamlined acquisition and treatment planning mode) and labeling changes. |
| P930022/S003 5/12/06 180-Day |
Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models. |
| P960040/S091 5/1/06 Real-Time |
VENTAK PRIZM VR, PRIZM DR, PRIZM HE VR, PRIZM HE DR, PRIZM 2 VE, PRIZM 2 DR, PRIZM AT Implantable Cardioverter Defibrillators | Guidant Corporation St. Paul, MN 55112 | Approval for an update the visual inspection criteria in GMAI (General Manufacturing Area Instruction) I00093. |
| P960040/S104 5/5/06 135-Day |
PRIZM/ VITALITY | Guidant Corporation St. Paul, MN 55112 | Change from a manual to an automated inspection of the solder balls on ball grid array modules. |
| P960040/S108 5/19/06 135-Day |
VITALITY Family of ICDs | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 | Approval for changes to the test software and test hardware used during electrical testing of the mixed mode integrated circuit (MMIC). |
| P970003/S064 5/4/06 Real-Time |
NeuroCybernetic Prosthesis (NCP) System | Cyberonics, Inc. Houston. TX 77058 | Approval for the VNS Therapy™ Perennia™ Model 303 Lead. |
| P970012/S020 5/12/06 180-Day |
Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models. |
| D970012/S029 5/23/06 Real-Time |
AMS 700™ Series Product Line Inflatable Penile Prostheses | American Medical Systems, Inc. Minnetonka, MN 55343 | Approval for design changes to the AMS 700 MS Pump: 1) poppet change; 2) spring/ball valve change; and 3) modification to the adhesive dams used to bond the valve block to the pump bulb. |
| P970038/S008 5/18/06 Real-Time |
Access® Hybritech® Free PSA Reagents on the Access® Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the Access PSA reagents for use on the UniCel® DxC 600i Synchron® Access® Clinical System. The device, as modified, will be marketed under the trade name Access® Free PSA Reagent on the Access® Immunoassay System. |
| P970043/S019 5/1/06 Real-Time |
LADAR™ 6000 Excimer Laser System | Alcon Laboratories, Inc. Orlando, FL 32826 | Approval for changes in the LADARVision® 4000 System including a new configuration of the illumination system, upgrades to the laser computer and operating system, and various other hardware and software changes intended to address compliance with EMI requirements, manage component obsolescence, reduce maintenance requirements, and enhance ergonomic and user interface features. The device, as modified, will be marketed under the trade name LADAR™ 6000 Excimer Laser System. |
| P970043/S020 5/1/06 Panel |
LADARVision® 4000 Excimer Laser System and the LADAR™ 6000 Excimer Laser System | Alcon Laboratories, Inc. Orlando, FL 32826 | Approval for the LADARVision® 4000 Excimer Laser System and the LADAR™ 6000 Excimer Laser System. These devices use a 6.5 mm optical zone and a 9.0 treatment zone and are indicated for wave-front guided CustomCornea® laser assisted in-situ keratomileusis (LASIK): 1) for the reduction or elimination of hyperopia and hyperopic astigmatism of +0.75 D to less that +5.00 D of sphere with up to -3.00 D of cylinder (which has a magnitude less than or equal to the sphere in minus cylinder convention) and up to +5.00 cycloplegic spherical equivalent at the spectacle plane; 2) in patients 21 years of age or older; and 3) in patients with documented stability of refraction for the prior 12 months, as demonstrated by a change in sphere and cylinder of less than or equal to 0.50 D. |
| P970043/S022 5/2/06 Panel |
LADARVision® 4000 Excimer Laser System and the LADAR™ 6000 Excimer Laser System | Alcon Laboratories, Inc. Orlando, FL 32826 | Approval for the LADARVision® 4000 Excimer Laser System and the LADAR™ 6000 Excimer Laser System. These devices use a 6.5 mm optical zone and a 9.0 treatment zone and are indicated for wave-front guided CustomCornea® laser assisted in-situ keratomileusis (LASIK): 1) for the reduction or elimination of mixed astigmatism 1.00 D to less than 5.00 D cycloplegic cylinder magnitude at the spectacle plane, which is greater than the sphere magnitude, and the cylinder and sphere have opposite signs; 2) in patients 21 years of age or older; and 3) in patients with documented stability of refraction for the prior 12 months, as demonstrated by a change in sphere and cylinder of less than or equal to 0.50 D. |
| P970043/S023 5/1/06 180-Day |
LADAR™ 6000 Excimer Laser System | Alcon Laboratories, Inc. Orlando, FL 32826 | Approval to increase the pulse repetition rate of the LADAR™ 6000 Excimer Laser from 60 Hz to 92 Hx. |
| P970051/S037 5/25/06 Real-Time |
Nucleus 24 Cochlear Implant System | Cochlear Americas Englewood, CO 80112 | Approval for 1) smaller and more cosmetic, ear-level controller (powered by two 675 hearing-aid batteries) and 2) a rechargeable lithium-ion battery – both for use with the modular Nucleus Freedom speech processor. |
| D980003/S005 5/1/06 135-Day |
Keramos Ceramic/Ceramic Total Hip System | Encore Medical, L.P. Austin, TX 78758 | Approval for changes to the grinding and polishing processes performed at CeramTec. |
| P980016/S062 5/12/06 180-Day |
Medtronic Virtuoso™ DR/VR Models D154A WG/D154VWC Implantable Cardioverter Defibrillators, Concerto - Virtuoso v 1.0 Software Application Model SW002 and Conexus Activator Model 27901 | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the Medtronic® Virtuoso™ DR/VR Models D154A WG/D154VWC Implantable Cardioverter Defibrillators and the Concerto - Virtuoso v 1.0 Software Application Model SW002. The Medtronic® Virtuoso™ DR Model D154AWG device is indicated as follows: The device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional class II/III heart failure. In addition, the device is indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias.Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP), and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in ICD-indicated patients with atrial septal lead placement and an ICD indication. Notes: 1) The ICD features of the Virtuoso device function the same as other approved Medtronic market-released ICDs. 2) Due to the addition of the OptiVol diagnostic feature, the Virtuoso indication is limited to NYHA functional class II/III heart failure patients who are indicated for an ICD. 3) The clinical value of the OptiVol fluid monitoring diagnostic feature has not been assessed in those patients who do not have fluid retention related symptoms due to heart failure. 4) The use of the device has not been demonstrated to decrease the morbidity related to atrial tachyarrhythmias. 5) The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 17%, and in terminating device classified atrial fibrillation (AF) was found to be 16.8%, in the VT/AT patient population studied. 6) The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 11.7% , and in terminating device classified atrial fibrillation (AF) was found to be 18.2%, in the AF-only patient population studied. The Medtronic® Virtuoso™ VR Model D154VWC is indicated as follows: The device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional class II/III heart failure. Notes: 1) The ICD features of the Virtuoso device function the same as other approved Medtronic market-released ICDs. 2) Due to the addition of the OptiVol diagnostic feature, the Virtuoso indication is limited to NYHA functional class II/III heart failure patients who are indicated for an ICD. 3) The clinical value of the OptiVol fluid monitoring diagnostic feature has not been assessed in those patients who do not have fluid retention related symptoms due to heart failure. |
| P980016/S064 5/12/06 180-Day |
Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models. |
| P980016/S072 5/8/06 Real-Time |
Gem DR® Model 7271, Gem® II DR Model 7273, Gem® II VR Model 7229, Gem® III DR Model 7275, Gem® III VR Model 7231, Marquis® DR Model 7274, Marquis® VR Model 7230, Maximo® DR Model 7278, Maximo® VR Model 7232, Intrinsic® Model 7288, Intrinsic® 30 Model 7287, EnTrust™ Models D153ATG, D153 VRC, D154ATG, D154VRC | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the addition of the support for the InSync III Marquis to the 2490G CareLink Monitor and the 2491 Device Data Management Application (DDMA) software, and the updates to the firmware used in the 2490G CareLink Monitor and updates to the 2491 DDMA software. |
| P980024/S002 5/10/06 180-Day |
UroVysion™ Bladder Cancer Kit | Abbott Molecular Inc. Des Plaines, IL 60018 | Approval for a manufacturing site located at Abbott Des Plaines, Des Plaines, Illinois. |
| P980035/S052 5/12/06 180-Day |
Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models. |
| P980041/S008 5/16/06 Real-Time |
Access® AFP Reagents on the Access® Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 | Approval for the ACCESS AFP reagents for use on the UniCel® DxC 600i Synchron® Access® Clinical System. The device, as modified, will be marketed under the trade name Access® AFP reagents on the Access® Immunoassay Systems. The Access AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative determination of alpha-fetoprotein (AFP) in: 1) Human serum, as an aid in the management of patients with non-seminomatous testicular cancer. 2) Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ONTD. The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography. |
| P980050/S020 5/12/06 180-Day |
Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models. |
| P990001/S023 5/12/06 180-Day |
Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models. |
| P990066/S023 5/5/06 Special |
Senographe DS Full Field Digital Mammography System | GE Healthcare General Electric Company Milwaukee, WI 53188 | Approval to correct a scale rule annotation on printed digital mammography images and corresponding labeling changes to the operator instructions. |
| P000025/S020 5/31/06 Real-Time |
New Diagnostic Interface Box II (DIB II) | MED-EL Corporation Durham, NC 27713 | Approval for New Diagnostic Interface Box II (DIB II). The device, as modified, will be marketed under the trade name DIB II and is intended to offer the clinician tools for different clinical applications with the MED-EL Cochlear Implant System. |
| P000032/S018 5/23/06 135-Day |
Her Option™ Cryoablation Therapy System | American Medical Systems Minnetonka, MN 55343 | Approval for a change in the joining process of the heater and thermocouple wires to the disposable tip. |
| P000039/S011 5/12/06 Real-Time |
AMPLATZER® Septal Occluder (ASO) Device, AMPLATZER® Duct Occluder and AMPLATZER® Delivery and Exchange System | AGA Medical Corporation Golden Valley, MN 55427 | Approval for the use of an alternate pigment to be used during manufacture of the PTFE tubing components of the Amplatzer® delivery and exchange system sheaths, dilators and loaders. |
| P010012/S081 5/1/06 135-Day |
CONTACK RENEWAL IS1/DR1 Cardiac Resynchronization Therapy Defibrillator (CRT-D) | Guidant Corporation St. Paul, MN 55112 | Approval for an update the visual inspection criteria in GMAI (General Manufacturing Area Instruction) I00093. |
| P010012/S099 5/5/06 135-Day |
RENEWAL | Guidant Corporation St. Paul, MN 55112 | Change from a manual to an automated inspection of the solder balls on ball grid array modules. |
| P010012/S103 5/19/06 135-Day |
RENEWAL Family of CRT-Ds | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 | Approval for changes to the test software and test hardware used during electrical testing of the mixed mode integrated circuit (MMIC). |
| P010015/S019 5/12/06 180-Day |
Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models. |
| P010031/S031 5/12/06 180-Day |
Medtronic Virtuoso™ DR/VR Models D154A WG/D154VWC Implantable Cardioverter Defibrillators, Concerto - Virtuoso v 1.0 Software Application Model SW002 and Conexus Activator Model 27901 | Medtronic, Inc. Minneapolis, MN 55432 | Approval for Concerto Model C154DWK Implantable Cardioverter Defibrillator and Concerto-Virtuoso v1.0 Software Application Model SW002. The Concerto Model C154DWK is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The system is also indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction ≤35% and a prolonged QRS duration. |
| P010031/S033 5/12/06 180-Day |
Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the Medtronic Model 2091 WB Wireless PC Card for use with Medtronic Model 9986 DeskTop/BOSS (SW Version 1.5) for the Medtronic CareLink Programmer (Model 2090) for all Medtronic and Vitatron Pacemaker and ICD Models. |
| P010031/S039 5/8/06 Real-Time |
InSync ICD® Model 7272, InSync Marquis™ Model 7277, InSync Maximo® Models 7303, and 7304, InSync Sentry® Models 7297 and 7299, InSync II Marquis™ Model 7289, InSync III Marquis™ Model 7279 | Medtronic, Inc. Minneapolis, MN 55432 | Approval for the addition of the support for the InSync III Marquis to the 2490G CareLink Monitor and the 2491 Device Data Management Application (DDMA) software, and the updates to the firmware used in the 2490G CareLink Monitor and updates to the 2491 DDMA software. |
| P010062/S004 5/30/06 135-Day |
Rigid Gas Permeable Contact Lenses (Boston Orthokeratology) | Bausch & Lomb, Inc. Rochester, NY 14609 | Approval for the addition of a cold oxygen plasma treatment step to the current manufacturing process for the Boston EQUALENS (itafluorofocon A), Boston EQUALENS II, and Boston Orthokeratology (oprifocon A) Shaping Lens. |
| P020016/S001 5/26/06 180-Day |
Total Temporomandibular Joint Replacement System | Walter Lorenz Surgical, Inc. Jacksonville, FL 32218 | Approval for a manufacturing site located at Walter Lorenz Surgical, Inc.’s Jacksonville , Florida facility for the wire electrical discharge machining manufacturing process. |
| P020024/S007 5/12/06 Real-Time |
AMPLATZER Septal Occluder (ASO) Device, AMPLATZER Duct Occluder and AMPLATZER Delivery and Exchange System | AGA Medical Corporation Golden Valley, MN 55427 | Approval for the use of an alternate pigment to be used during manufacture of the PTFE tubing components of the Amplatzer® delivery and exchange system sheaths, dilators and loaders. |
| P020026/S014 5/17/06 Real-Time |
CYPHER™ Sirolimus-Eluting Coronary Stent on the RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System (CYPHER Stent) | Cordis Corporation Miami Lakes, FL 33014 | Approval to implement new orthogonal methods to quantitate drug content, impurities and degradation products for the CYPHER Stent. Based upon these new methods, you have also requested approval for new specifications for impurities and degradation products for the CYPHER Stent at finished goods release testing and on stability. The device, as modified, will be marketed under the trade name CYPHER™ Sirolimus-Eluting Coronary Stent on the RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length £ 30mm in native coronary arteries with reference vessel diameter of ≥ 2.5 mm to ≤ 3.5 mm. |
| P020036/S001 5/12/06 180-Day |
SMART™ Control Nitinol Stent System | Cordis Corporation Miami Lakes, FL 33014 | Approval for a manufacturing site located at Cordis de Mexico, Chihuahua, Mexico. |
| P030005/S029 5/5/06 135-Day |
CONTAK/ RENEWAL | Guidant Corporation St. Paul, MN 55112 | Change from a manual to an automated inspection of the solder balls on ball grid array modules. |
| P030017/S012 5/12/06 Real-Time |
PRECISION™ Spinal Cord Stimulation (SCS) System | Advanced Bionics Slymar, CA 91342 | Approval for the Implanted Pulse Generator (IPG)/External Trial Stimulator (ETS) Firmware Version 3.0. |
| P030017/S014 5/24/06 180-Day |
PRECISION™ Spinal Cord Stimulation (SCS) System | Advanced Bionics Sylmar, CA 91342 | Approval for the Charger 2.0. |
| P030030/S003 5/23/06 180-Day |
Tegress™ Urethral Implant | C.R. Bard, Inc. Covington, CA 30014 | Approval for modifications to the postapproval study protocol. |
| P030031/S002 5/5/06 180-Day |
NaviStar ThermoCool and Celsius ThermoCool Catheters | Biosense Webster Diamond Bar, CA 91765 | Approval for a manufacturing site located at Biosense Webster, Inc., Chihuahua, Mexico. |
| P030052/S001 5/10/06 180-Day |
UroVysion Bladder Cancer Kit | Abbott Molecular Inc. Des Plaines, IL 60018 | Approval for a manufacturing site located at Abbott Des Plaines, Des Plaines, Illinois. |
| P040002/S005 5/17/06 Real-Time |
Endologix PowerLink® System | Endologix, Inc. Irvine, CA 92618 | Approval for a new version of the Visiflex delivery catheter for both the bifurcated and straight stent grafts. |
| P040023/S007 5/26/06 Special |
Duraloc Option Ceramic Hip System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 | Approval for an additional label being added to the device outer package that states, “WARNING: Only compatible with Option series Implants”. |
30-Day Notices (135 Day Supplement was not required)
| P830060/S059 5/11/06 |
VENTAK | Guidant Corporation St. Paul, MN 55112 | Changes to the Limulus Amebocyte Lysate (LAL) sampling plan. |
| P830060/S060 5/12/06 |
VENTAK | Guidant Corporation St. Paul, MN 55112 | Changes to the bioburden sampling plan. |
| P860057/S034 5/12/06 |
Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 | Change in wireforming from a manual process to an automated process, and introduction of a cleaning method to remove lubricant with solvent. |
| P910023/S107 5/23/06 |
Cadence, Cadet, Contour, Angstrom, Profile, Photon, Epic and Atlas ICD Families | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Use of an alternate encapsulant material in ICD/CRT-D hybrid production. |
| P910073/S064 5/11/06 |
ENDOTAK, ENDURANCE, RELIANCE | Guidant Corporation St. Paul, MN 55112 | Changes to the Limulus Amebocyte Lysate (LAL) sampling plan. |
| P910073/S065 5/12/06 |
ENDOTAK | Guidant Corporation St. Paul, MN 55112 | Changes to the bioburden sampling plan. |
| P910077/S059 5/11/06 |
VENTAK PRx, MINI I-IV | Guidant Corporation St. Paul, MN 55112 | Changes to the Limulus Amebocyte Lysate (LAL) sampling plan. |
| P910077/S060 5/12/06 |
VENTAK PR, VENTAK MINI | Guidant Corporation St. Paul, MN 55112 | Changes to the bioburden sampling plan. |
| P930035/S015 5/11/06 |
VENTAK P2 | Guidant Corporation St. Paul, MN 55112 | Changes to the Limulus Amebocyte Lysate (LAL) sampling plan. |
| P930035/S016 5/12/06 |
VENTAK P2 | Guidant Corporation St. Paul, MN 55112 | Changes to the bioburden sampling plan. |
| P940008/S021 5/11/06 |
Res-Q | Guidant Corporation St. Paul, MN 55112 | Changes to the Limulus Amebocyte Lysate (LAL) sampling plan. |
| P940008/S022 5/12/06 |
RES-Q | Guidant Corporation St. Paul, MN 55112 | Changes to the bioburden sampling plan. |
| P940031/S053 5/12/06 |
VIGOR | Guidant Corporation St. Paul, MN 55112 | Changes to the bioburden sampling plan. |
| P950001/S016 5/11/06 |
SELUTE | Guidant Corporation St. Paul, MN 55112 | Changes to the Limulus Amebocyte Lysate (LAL) sampling plan. |
| P950001/S017 5/12/06 |
SELUTE | Guidant Corporation St. Paul, MN 55112 | Changes to the bioburden sampling plan. |
| P960004/S035 5/11/06 |
ThinLine, FINELINE | Guidant Corporation St. Paul, MN 55112 | Changes to the Limulus Amebocyte Lysate (LAL) sampling plan. |
| P960004/S036 5/12/06 |
THINLINE | Guidant Corporation St. Paul, MN 55112 | Changes to the bioburden sampling plan. |
| P960006/S020 5/11/06 |
SWEET TIP Rx, FLEXTEND | Guidant Corporation St. Paul, MN 55112 | Changes to the Limulus Amebocyte Lysate (LAL) sampling plan. |
| P960006/S021 5/12/06 |
SWEET TIP | Guidant Corporation St. Paul, MN 55112 | Changes to the bioburden sampling plan. |
| P960040/S121 5/11/06 |
VENTAK AV/VR/PRIZM | Guidant Corporation St. Paul, MN 55112 | Changes to the Limulus Amebocyte Lysate (LAL) sampling plan. |
| P960040/S122 5/12/06 |
VITALITY | Guidant Corporation St. Paul, MN 55112 | Changes to the bioburden sampling plan. |
| D970003/S070 5/12/06 |
DISCOVERY, PULSAR MAX, INSIGNIA, NEXUS, INTELIS | Guidant Corporation St. Paul, MN 55112 | Changes to the bioburden sampling plan. |
| P010012/S125 5/11/06 |
CONTAK CD, EASYTRACK | Guidant Corporation St. Paul, MN 55112 | Changes to the Limulus Amebocyte Lysate (LAL) sampling plan. |
| P010012/S126 5/12/06 |
CONTAK RENEWAL CD | Guidant Corporation St. Paul, MN 55112 | Changes to the bioburden sampling plan. |
| P030005/S034 5/12/06 |
CONTAK RENEWAL TR | Guidant Corporation St. Paul, MN 55112 | Changes to the bioburden sampling plan. |
| P030025/S029 5/1/06 |
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corp. Maple Grove, MN 55311 | Elimination of the Final Functional Audits (FFA). |
| P030025/S030 5/1/06 |
TAXUS™ Express2™ Coronary Stent System | Boston Scientific Corp. Maple Grove, MN 55311 | Modification of the equipment nozzle to the mold used for making the manifold. |
| P030054/S028 5/23/06 |
Epic HF and Atlas+ HF CRT-D Families | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Use of an alternate encapsulant material in ICD/CRT-D hybrid production. |
| P040016/S009 5/1/06 |
Liberté™ Coronary Stent System | Boston Scientific Corp. Maple Grove, MN 55311 | Modification of the equipment nozzle to the mold used for making the manifold. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 60
Summary of PMA Originals Under Review
Total Under Review: 101
Total Active: 45
Total On Hold: 56
Number Greater Than 180 Days: 5
Summary of PMA Supplements Under Review
Total Under Review: 433
Total Active: 266
Total On Hold: 167
Number Greater Than 180 Days: 14
Summary of All PMA Submissions Received
Originals: 3
Supplements: 122
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 60
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 149.1
FDA Time: 102.3 Days MFR Time: 46.8 Days
Updated March 25, 2008
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