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
| P050046 4/13/07 |
ACUITY™ Steerable Lead Models 4554, 4555 and 4556 | Guidant CRM St. Paul , MN 55112 |
Approval for the ACUITY™ Steerable Lead Models 4554, 4555, and 4556. The Guidant ACUITY™ Steerable IS-1 coronary venous, steroid-eluting, dual-electrode pace/sense leads are transvenous leads intended for chronic, left-ventricular pacing and sensing via the coronary veins when used in conjunction with a compatible pulse generator. Extended bipolar pacing and sensing is available using ACUITY™ Steerable with an RV pace/sense/defibrillation lead or a bipolar RV pace/sense lead. |
| P060031 4/27/07 |
Bio-Rad MONOLISA™ Anti-HBc EIA | Bio-Rad Laboratories Redmond , WA 98052 |
Approval for the Bio-Rad MONOLISA™ Anti-HBc EIA. The device is indicated for: The MONOLISA™ Anti-HBc EIA is an enzyme immunoassay intended for use in the qualitative detection of total antibodies (IgG/IgM) to hepatitis B core antigen (anti-HBc) in human serum and plasma (potassium EDTA, sodium citrate, ACD (acid citrate dextrose), lithium heparin and sodium heparin). Assay results may be used with other HBV serological markets for the laboratory diagnosis of HBV disease associated with HBV infection. |
PMA Supplemental Approvals
| P890057/S019 4/25/07 Real-Time |
Model 3100A High Frequency Oscillatory Ventilator | Bird Products Corporation Palm Springs , CA 92262 |
Approval for the modification of the breathing circuit to include two filters, one in the inspiratory limb after the gas supply line and relieve valve and another at the expiratory limb before the dump valve. |
| P900023/S046 4/24/07 Real-Time |
AB5000/BVS 5000 Circulatory Support System | Abiomed, Inc. Danvers , MA 01923 |
Approval for modifications to the AB5000 Ventricle cannula restraint system, extended shelf life (2 years) for the AB5000 Ventricle, and reclassification of a precaution to a warning for the BVS 5000. |
| P900052/S013 4/5/07 135-Day |
PORT-A-CATH® Epidural Implantable Access System | Smith Medical MD, Inc. St. Paul , MN 55112 |
Approval for a second operator inspection for outlet tube and insert hole alignment to confirm proper alignment of the outlet tube. |
| P910023/S131 4/17/07 Real-Time |
Housecall Plus™ System | St. Jude Medical CRMD Sunnyvale , CA 94086 |
Approval for modifications to the St. Jude Medical Housecall Plus transtelephonic monitoring system, Merlin.net V2.0, which will allow the physician to view currently available web portal. In addition, the receiver software has been modified to improve the communication efficiency. |
| P930014/S017 4/27/07 180-Day |
AcrySof IQ Model SN60WF Posterior Chamber Intraocular Lens | Alcon Research, Ltd Fort Worth , TX 76134 |
Approval for labeling changes. |
| P960004/S039 4/18/07 Real-Time |
FINELINE II/ Thinline II Sterox Leads | Guidant Corporation St. Paul , MN 55112 |
Approval for electrode tip component modifications and medical adhesive replacement. |
| P970003/S078 4/12/07 Special |
VNS Therapy™ System | Cyberonics, Inc Houston , TX 77058 |
Approval for the addition of detailed information contained in the approved test to the figures provided in the labeling to provide further clarification concerning the proper Lead implant technique. Additionally, further details were provided to stress the importance of proper strain relief placement (i.e. proper tie-down location and strain relief bend). |
| P990001/S030 4/25/07 Real-Time |
L289-010A/B Integrated Circuit Controller for the Vitatron C- and T- Pacemaker Models C60A3, C20A3, T60A1, and T20A1 | Medtronic, Inc. / Vitatron, B.V. Shoreview , MN 55123 |
Approval for the L289-010A/B Integrated Circuit Controller for the Vitatron C- and T- pacemaker Models C60A3, C20A3, T60A1, and T20A1. |
| P990004/S011 4/13/07 Real-Time |
Surgifoam Absorbable Gelatin Sponge Surgiflo Hemostatic Matrix |
Ethicon, Inc., J & J Wound Management Somerville , NJ 08876 |
Approval for a labeling change allowing wording that will recommend the drawing of 2 to 5 ml saline or thrombin for use with Surgiflo Hemostatic Matrix. |
| P990066/S027 4/13/07 Real-Time |
Senographe DS and Essential Systems | GE Healthcare Milwaukee , WI 53210 |
Approval for a change in the acceptance criteria for the detectors. |
| P990066/S028 4/13/07 Real-Time |
Senographe DS and Essential Systems | GE Healthcare Milwaukee , WI 53210 |
Approval for 1) a new computer; 2) modification of the software; 3) addition of a third party software program; 4) changes in the proprietary software; and 5) replacement of the uninterruptible power supply (UPS) with a smaller type. |
| P990081/S005 4/11/07 Special |
Ventana Pathway® HER-2 (Clone CB11) | Ventana Medical Systems, Inc. Tucson , AZ 85755 |
Approval for change in the labeling to include the Pathway HER-2 4 in 1 control slides. |
| P000013/S008 4/26/07 Real-Time |
Osteonics ABC / Trident Systems | Howmedica Osteonics Corp. (Stryker Orthopedics) Mahwah , NJ 07430 |
Approval for a new locking mechanism design for the Trident Acetabular System (Trident Alumina Inserts and Trident Acetabular Shells), as well as associated revisions to the package insert. This design modification is intended to allow for ease of insertion of the alumina ceramic insert. The device, as modified, will be marketed under the trade name Trident II Acetabular System (Trident II Alumina Inserts, Trident II Acetabular Shells) and is indicated for patients requiring primary or revision total hip arthroplasty due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant), or inflammatory joint disease. |
| P000029/S019 4/26/07 135-Day |
Deflux® Injectable Gel | Q-Med Scandinavia, Inc. Princeton , NJ 08540 |
Approval for two new water systems (for the production of purified water (PW) and for water for injection (WFI)) and the equipment for the production, storage and distribution of PW and WFI. |
| P000029/S020 4/19/07 180-Day |
Deflux® Injectable Gel | Q-Med Scandinavia, Inc. Princeton , NJ 08540 |
Approval for a labeling change to delete the contraindication for Deflux® in duplex systems, and to replace it with a precaution. |
| P000037/S012 4/11/07 Special |
On-X® Prosthetic Heart Valve, Models ONXA, ONXAC, ONXM, and ONXMC | Medical Carbon Research Institute (MCRI), LLC Austin , TX 78754 |
Approval for warning against resterilization. |
| P000039/S012 4/25/07 180-Day |
AMPLATZER Septal Occluder | AGA Medical Corp. Golden Valley , MN 55427 |
Approval for a new delivery system and modifications to the device packaging. The devices, with the modified delivery systems, will be marketed under the trade name TorqVue™ Delivery and Exchange Systems. |
| P010014/S003 4/20/07 135-Day |
Oxford Meniscal Unicompartmental Knee System | Biomet Orthopedics, Inc. Warsaw , IN 46581 |
Approval for a change to Ticona GUR 1050 UHMWPE from Montel/Basell 1900H UHMWPE. |
| P010031/S057 4/17/07 180-Day |
Medtronic Concerto Models C154DWK and C164AWK ICD Systems and Concerto-Virtuoso v1.2 Software Application Model SW002 |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the Medtronic Concerto Models C154DWK and C164AWK ICD systems and Concerto-Virtuoso v1.2 Software Application Model SW002. The device, as modified, will be marketed under the trade name Medtronic Concerto Models C154DWK and C164AWK ICD systems and is indicated as follow: The Concerto is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. In addition, the device is indicated for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias. 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. 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. |
| P020024/S010 4/25/07 180-Day |
AMPLATZER Duct Occluder | AGA Medical Corp. Golden Valley , MN 55427 |
Approval for a new delivery system and modifications to the device packaging. The devices, with the modified delivery systems, will be marketed under the trade name TorqVue™ Delivery and Exchange Systems. |
| P020026/S004 4/13/07 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 , FL 33102 |
Approval for a new elution test method and revised elution specifications. |
| P020045/S021 4/18/07 Real-Time |
Freezor Cardiac CryoAblation Catheters - Freezor Xtra and Freezor MAX Surgical CryoAblation Catheters and CCT.2 CryoConsole System | Applied Physics Santa Fe , MN 87594 |
Approval for changes to the leak detection system in the Freezor catheter and Freezor Xtra devices from a single bare stainless steel wire to a duplex insulated wire made of two electrodes. |
| P020050/S005 4/9/07 180-Day |
WaveLight ALLEGRETTO WAVE EYE-Q Excimer Laser System | WaveLight AG Bavaria , Germany 91058 |
Approval for a change in the 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) for: 1) the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 diopters (D) at the spectacle plane in patients who are 21 years of age or older 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) the wavefront-guided (WFG) reduction or elimination of up to -7.00 diopters (D) of spherical equivalent myopia or myopia with astigmatism, with up to -7.00 D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane in patients who are 18 years of age or older with documentation of a stable manifest refraction defined as ≤0.50 D of preoperative spherical shift over one year prior to surgery. |
| P030008/S005 4/9/07 180-Day |
WaveLight ALLEGRETTO WAVE EYE-Q Excimer Laser System | WaveLight AG Bavaria , Germany 91058 |
Approval for a change in the 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) for: 1) the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 diopters (D) at the spectacle plane in patients who are 21 years of age or older 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) the wavefront-guided (WFG) reduction or elimination of up to -7.00 diopters (D) of spherical equivalent myopia or myopia with astigmatism, with up to -7.00 D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane in patients who are 18 years of age or older with documentation of a stable manifest refraction defined as ≤0.50 D of preoperative spherical shift over one year prior to surgery. |
| P030031/S004 4/23/07 Real-Time |
NaviStar™ ThermoCool® Deflectable Diagnostic/Ablation Catheter and Celsius™ ThermoCool® Deflectable Diagnostic/Ablation Catheter | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for merging the labeling for the two approved indications for the NaviStar ThermoCool Diagnostic/Ablation Catheters (atrial flutter under P030031, and ventricular tachycardia under P040036) and updating the labeling for the Celsius ThermoCool which remains approved for treatment of atrial flutter only. |
| P030053/S004 4/27/07 180-Day |
Mentor MemoryGel Silicone Gel-filled Breast Implants | Mentor Corporation Santa Barbara , CA 93111 |
Approval to revise the post-approval study to allow for the voluntary rather than mandatory participation of all patients, irrespective of the type of implant (i.e., MemoryGel™ implant or saline implants) they receive. |
| P040036/S002 4/23/07 Real-Time |
NaviStar™ ThermoCool® Deflectable Diagnostic/Ablation Catheter and Celsius™ ThermoCool® Deflectable Diagnostic/Ablation Catheter | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for merging the labeling for the two approved indications for the NaviStar ThermoCool Diagnostic/Ablation Catheters (atrial flutter under P030031, and ventricular tachycardia under P040036) and updating the labeling for the Celsius ThermoCool which remains approved for treatment of atrial flutter only. |
| P040037/S003 4/24/07 180-Day |
GORE VIABAHN® Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86003 |
Approval for the addition of a 5 mm diameter endoprosthesis. |
| P050025/S002 4/10/07 180-Day |
Endotex® NexStent® Carotid Stent and Monorail® | Boston Scientific Cupertino , CA 95014 |
Approval of the post-approval study protocol. |
30-Day Notices (135 Day Supplement was not required)
| P900060/S038 4/26/07 |
CarboMedics Carbo-Seal® and Valsalva Ascending Aortic Prosthesis | CarboMedics, Inc. Austin , TX 78752 |
Additional sterilizer for sterilizing CarboMedics Carbo-Seal® and Valsalva Ascending Aortic Prosthesis devices. |
| P920023/S020 4/17/07 |
Urolume Urethral Stent | American Medical Systems Minnetonka , MN 55343 |
Additional in-process cytotoxicity testing site for the device. |
| P960028/S019 4/26/07 |
ReZoom Multifocal IOLs | Associate Regulatory Affairs Specialist Santa Ana , CA 92705 |
Reduce operator handling of lenses by eliminating the 100% visual inspection processing step conducted at post-tumbling for all of the soft acrylic IOLs. |
| P960028/S020 4/26/07 |
ReZoom Multifocal Intraocular Lenses, Models NXG1 | Associate Regulatory Affairs Specialist Santa Ana , CA 92705 |
Change in the 100% in-process dimensional inspection step for all soft acrylic intraocular lenses. |
| D970012/S036 4/17/07 |
AMS 700 Inflatable Penile Prosthesis and Ambicor Inflatable Penile Prosthesis | American Medical Systems Minnetonka , MN 55343 |
Additional in-process cytotoxicity testing site for the devices. |
| P980040/S013 4/26/07 |
Sensar Acrylic IOLs | Associate Regulatory Affairs Specialist Santa Ana , CA 92705 |
Reduce operator handling of lenses by eliminating the 100% visual inspection processing step conducted at post-tumbling for all of the soft acrylic IOLs. |
| P980040/S014 4/26/07 |
Sensar Acrylic Intraocular Lenses, Models AR40e, AR40M, AR40E, AR40x, and AR40XEM | Associate Regulatory Affairs Specialist Santa Ana , CA 92705 |
Change in the 100% in-process dimensional inspection step for all soft acrylic intraocular lenses. |
| P990080/S021 4/26/07 |
Tecnis® Acrylic IOLs | Associate Regulatory Affairs Specialist Santa Ana , CA 92705 |
Reduce operator handling of lenses by eliminating the 100% visual inspection processing step conducted at post-tumbling for all of the soft acrylic IOLs. |
| P990080/S022 4/26/07 |
Tecnis Acrylic Intraocular Lenses, Model AZ9003 | Associate Regulatory Affairs Specialist Santa Ana , CA 92705 |
Change in the 100% in-process dimensional inspection step for all soft acrylic intraocular lenses. |
| P000029/S024 4/19/07 |
Deflux® Injectable Gel | Q-MED Scandinavia, Inc. Princeton , NJ 08540 |
Change in the bioburden testing of the Deflux needles. |
| P000029/S025 4/20/07 |
Deflux® Injectable Gel | Q-MED Scandinavia, Inc. Princeton , NJ 08540 |
Change involving bioburden testing of all water samples. |
| P000029/S026 4/20/07 |
Deflux® Injectable Gel | Q-MED Scandinavia, Inc. Princeton , NJ 08540 |
Change the autoclaving procedure for equipment and utensils. |
| P000029/S028 4/20/07 |
Deflux® Injectable Gel | Q-MED Scandinavia, Inc. Princeton , NJ 08540 |
Change the maintenance of the water system used for water for injection (WFI). |
| P000029/S029 4/20/07 |
Deflux® Injectable Gel | Q-MED Scandinavia, Inc. Princeton , NJ 08540 |
Changes in the calibration test ranges and limits for probes in autoclaves. |
| P000044/S016 4/16/07 |
VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator and VITROS Immunodiagnostic Products Confirmatory Kit | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Addition of a raw material supplier for uncoated microwells. |
| P000053/S008 4/17/07 |
AMS 800 Artificial Urinary Sphincter | American Medical Systems Minnetonka , MN 55343 |
Additional in-process cytotoxicity testing site for the device. |
| P010020/S004 4/17/07 |
Acticon Neosphincter Artificial Bowel Sphincter | American Medical Systems Minnetonka , MN 55343 |
Additional in-process cytotoxicity testing site for the device. |
| P010021/S010 4/16/07 |
VITROS Immunodiagnostic Products HCV Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Addition of a raw material supplier for uncoated microwells. |
| P020004/S020 4/20/07 |
Gore EXCLUDER® AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86003 |
Change to modify the destructive testing procedure for the nitinol wire used for the manufacture of the EXCLUDER® AAA Endoprosthesis. |
| P020009/S037 4/4/07 |
Express 2 Monorail (MR) & Over-the-Wire (OTW) Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Removal of a redundant inspection step in the manufacture of the device. |
| P020009/S038 4/4/07 |
Express 2™Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Modification to the proximal weld in-process acceptance criteria in the manufacture of the device. |
| P020047/S009 4/4/07 |
MULTI-LINK VISION® RX Coronary Stent System and MULTI-LINK MINI VISION® RX Coronary Stent System | Abbott Vascular Cardiac Therapies Temecula , CA 92591 |
Replacement of the existing bonding equipment with a new heat bonder. |
| P030005/S043 4/13/07 |
CONTAK RENEWAL TR Family of Cardiac Resynchronization Therapy Pacemakers (CRT-P) |
Guidant Corporation St. Paul , MN 55112 |
Two new suppliers of resistors used in the CONTAK RENEWAL TR family of devices. |
| P030017/S021 4/13/07 |
Precision Spinal Cord Stimulator System | Advanced Bionics Sylmar , CA 91342 |
Change in the adhesion process for the ARTISAN 2 x 8 Surgical Lead electrodes of the device. |
| P030025/S045 4/4/07 |
Taxus Express 2™ Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Removal of a redundant inspection step in the manufacture of the device. |
| P030025/S046 4/4/07 |
Taxus™ Express 2 Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Modification to the proximal weld in-process acceptance criteria in the manufacture of the device. |
| P030026/S013 4/6/07 |
VITROS Immunodiagnostic Products anti-HBc IgM Reagent Pack and VITROS Immunodiagnostic Products anti-HBc IgM Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Addition of a raw material supplier for uncoated microwells. |
| P040002/S010 4/4/07 |
Powerlink System with Visiflex Delivery Catheter System | Endologix, Inc. Irvine , CA 92618 |
Change to the front sheath subassembly of the Visiflex Delivery System. |
| P040002/S011 4/13/07 |
Powerlink System with Visiflex Delivery Catheter System | Endologix, Inc. Irvine , CA 92618 |
Alternate supplier of ePTFE graft used in the Powerlink System stent gräf subassembly. |
| P040011/S001 4/23/07 |
Dako c-Kit pharmDx™ | Dako North America, Inc. Carpinteria , CA 93013 |
Change to perform target retrieval at an increased temperature and shorter incubation time under pressure. |
| P040016/S023 4/4/07 |
Liberté™ Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Modification to the proximal weld in-process acceptance criteria in the manufacture of the device. |
| P040042/S010 4/13/07 |
IBI Therapy™ Dual 8™ Ablations Catheters | Irvine Biomedical, Inc. Irvine , CA 92614 |
Change to add a new supplier for the isolation transformer for the 1500T6 ( USA) RT Generator. |
| P050012/S009 4/10/07 |
DexCom STS System | DexCom, Inc. San Diego , CA 92121 |
Automation for conformal coating removal in the manufacture of the device. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 61
Summary of PMA Originals Under Review
Total Under Review: 79
Total Active: 22
Total On Hold: 57
Number Greater Than 180 Days: 2
Summary of PMA Supplements Under Review
Total Under Review: 456
Total Active: 275
Total On Hold: 181
Number Greater Than 180 Days: 16
Summary of All PMA Submissions Received
Originals: 5
Supplements: 113
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 61
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 196.4
FDA Time: 147.3 Days MFR Time: 49.1 Days
Updated May 15, 2007
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