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Medical Devices
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October 2004 PMA Approvals
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
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
| P030011 10/15/04 |
Syncardia Temporary Cardio West Total Artificial Heart (TAH-t) | Syncardia Systems, Inc. Tucson, AZ 85713 |
Approval for the Syncardia Temporary Cardio West Total Artificial Heart (TAH-t). The device is indicated for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. Also, the temporary CardioWest Total Artificial Heart (TAH-t) is intended for use inside the hospital. |
| P040002 10/29/04 |
Endologix Powerlink System Bifurcated Infrarenal Stent Grafts: 25-16-135BL, 25-16-155BL, 25-16-140BL, 28-16-135BL, 28-16-155BL, 28-16-140BL Limb Extension Model Numbers: 16-16-55L, 16-16-88L, 20-20-55L Proximal Cuff Model Numbers: 25-25-55L, 25-25-75L, 28-28-55L, 28-28-75L |
Endologix, Inc. Irvine, CA 92618 |
Approval for the Endologix PowerLink System. The Powerlink System bifurcated models and proximal cuff and limb extension accessories are indicated for endovascular treatment in patients with AAA. The Endologix PowerLink System is indicated for patients with suitable aneurysm morphology for endovascular repair, including: 1) Adequate iliac/femoral access compatible with the required delivery systems (a diameter of >= 7 mm). 2) Non-aneurysmal aortic neck between the renal arteries and the aneurysm. 3) Aortic length >= 1.0 cm longer than the body portion of the chosen bifurcated model. 4) Common iliac artery distal fixation site. |
| P040003 10/22/04 |
ExAblate® 2000 System | InSightec – North America Dallas, TX 75207 |
Approval for the ExAblate 2000 System. The device is indicated for ablation of uterine fibroid tissue in pre-or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and have completed child bearing. |
| P040006 10/26/04 |
CHARITE™ Artificial Disc | DePuy Spine, Inc. Raynham, MA 02767 |
Approval for the CHARITE Artificial Disc. The device is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have no more than 3 mm of spondylolisthesis at the involved level. Patients receiving the CHARITE Artificial Disc should have failed at least six months of conservative treatment prior to implantation of the CHARITE Artificial Disc. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
| P830055/S089 10/14/04 Real-Time |
LCS Total Knee System | DePuy Orthopaedics, Inc. Warsaw, IN 56481 |
Approval for the addition of 29 mm MBT Revision sleeves, size medium LCS Complete femoral augment blocks, and thicker MBT Revision tibial trays to the existing system to provide surgeons with a full range of implant options for total knee arthroplasty. |
| P840002/S011 10/1/04 180-Day |
Stat Pace II | CardioCommand, Inc. Tampa, FL 33607 |
Approval for manufacturing sites located at Martech Medical Products, Baja California, Mexico and Harleysville, Pennsylvania. |
| P890003/S077 10/19/04 Real-Time |
Model 2490G/ 2490H/2490J CareLink Monitors for use with Model 2491 DDMA Software | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for Model 2490G/ 2490H/2490J CareLink Monitors for use with Model 2491 DDMA Software. |
| P890003/S078 10/25/04 Real-Time |
Medtronic Model 2490E & 2490 D CareLink Monitors and Model 2491 DDMA Software for InSync II Protect Model 7295, InSync Maximo Model 7303, Onyx VR Model 7290Cx, Intrinsic 30 Model 7287 and Intrinsic Model 7288 Implantable Devices | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the Model 2490E & 2490D CareLink Monitors and Model 2491 DDMA Software to allow their use with InSync II Protect Model 7295, InSync Maximo Model 7303, Onyx VR Model 7290Cx, Intrinsic 30 Model 7287 and Intrinsic Model 7288 Implantable Devices. The CareLink system is indicated for use by a patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection. |
| P920023/S018 10/15/04 Real-Time |
UroLume® Endoprosthesis | American Medical Systems Minnetonka, MN 55343 |
Approval for the use of NuSil Med 360 (1,000 cP) to lubricate the delivery tool and to change the positioning of the grapple portion of the delivery tool. |
| P950029/S021 10/27/04 Special |
Symphony and ELA Rhapsody Pacemakers | ELA Medical, Inc. Plymouth, MN 55441 |
Approval for modifications to the labeling for the Symphony and ELA Rhapsody Pacemakers to include instructions about testing, sensing or pacing while the pacemaker is out of the pocket. |
| P960040/S046 10/29/04 Real-Time |
Diagnostic Restoration Tool (DRT) Model 2725 Version 2.2 | Guidant Corporation St. Paul, MN 55112 |
Approval for the Diagnostic Restoration Tool (DRT) Model 2725 Version 2.2. |
| P960040/S047 10/29/04 Real-Time |
Model 2844 Version 3.8 | Guidant Corporation St. Paul, MN 55112 |
Approval for the Programmer’s application software Model 2844 Version 3.8. |
| P980003/S013 10/14/04 Real-Time |
Chilli II Cooled Ablation Catheter | Boston Scientific Corporation San Jose, CA 95134 |
Approval for changes made to the internal distal tip configuration and the catheter shaft as well as changes in the manufacturing process to bond the steering mechanism to the braided shaft for the Chilli II Cardiac Ablation Catheter. |
| P980048/S003 10/6/04 180-Day |
BAK/C® Vista® Cervical Interbody Fusion Device | Zimmer Spine Inc. Minneapolis, MN 55439 |
Approval for the BAK/C® Vista® device, a modification to the already approved BAK/C® device. The BAK/C® Vista® differs from the BAK/C® device in the following manners: 1) The BAK/C® Vista® has two large offset superior-inferior (SI) holes for bone ingrowth whereas the BAK/C® has many small holes at various circumferential and longitudinal locations, and 2) the BAK/C® Vista® is made of PEEK® OPTIMA LT1 and the BAK/C® is made of titanium (Ti-6A1-4V). The device, as modified, will be marketed under the trade name BAK/C® Vista® and is indicated for use in skeletally mature patients with degenerative disc disease DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. BAK/C® implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. |
| P980053/S007 10/27/04 180-Day |
Durasphere® EXP | Carbon Medical Technologies, Inc. St. Paul, MN 55110 |
Approval for 1 ml syringes with synthetic rubber stoppers. These syringes are intended to store Durasphere® EXP. |
| P990020/S017 10/28/04 180-Day |
AneuRx Stent Graft with Xcelerant Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for modifications made to the AneuRx Delivery System, a change in sterilization method, and changes to the instructions for use. |
| P000013/S005 10/22/04 Real-Time |
Osteonics ABC/Trident Systems | Howmedica Osteonics Corporation Mahwah, NJ 07432 |
Approval for expanded indications for use (inflammatory joint disease and revision hip arthroplasty) as well as revisions to the package insert and patients labeling. |
| P000018/S041 10/4/04 180-Day |
Beta-Cath™ System | Novoste Corporation Norcross, GA 30093 |
Approval for a manufacturing site located in Norcross, Georgia, to process radiation source trains for the Beta-Cath System. |
| P000043/S009 10/18/04 180-Day |
TMx-2000™ BPH | American Medical Systems Minnetonka, MN 55343 |
Approval for a manufacturing site at American Medical Systems (AMS), Minnetonka, Minnesota. AMS will duplicate manufacture the temperature sensor and reference probe and conduct laptop imaging and console burn-in. |
| P010003/S004 10/20/04 Special |
CryoLife BioGlue® Surgical Adhesive | CryoLife, Inc. Kennesaw, GA 30144 |
Approval for adding a boxed warning to be added to the labeling. |
| P010012/S033 10/29/04 Real-Time |
Model 2844 Version 3.8 | Guidant Corporation St. Paul, MN 55112 |
Approval for the Programmer’s application software Model 2844 Version 3.8. |
| P010031/S015 10/26/04 180-Day |
InSync Sentry™ Model 7297 ICD and Model 9998 Application Software Version 1.2 | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the InSync Sentry™ Model 7297 ICD and Model 9998 Application Software Version 1.2. The device 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 ARS duration >= 130ms. |
| P010031/S017 10/19/04 Real-Time |
InSync Maximo™ Model 7303 and Model 9998 Application Software Version 1.2 | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for a software update to the Model 9998 Application Software. |
| P020004/S007 10/20/04 180-Day |
Gore EXCLUDER™ Bifurcated Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Approval for the format to be used for a clinical update that will be provided to physician users at least annually. |
| P020045/S006 10/26/04 Real-Time |
9F Freezor® Max Surgical Cardiac CryoAblation Device | CryoCath Technologies, Inc. Kirkland, Montreal, Canada H9H 5H3 |
Approval for the 9F Freezor Max Surgical Cardiac CryoAblation Device. The device is indicated for minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. |
| P030017/S002 10/1/04 Real-Time |
PRECISION™ Spinal Cord Stimulation (SCS) System | Advanced Bionics Sylmar, CA 91342 |
Approval for the model SC-1110 implanted pulse generator (IPG), the model SC-5110 External Trial Stimulator (ETS), the model SC-5210 Remote Control and updates to the clinician Programmer. |
| P030025/S006 10/21/04 Special |
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire) | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for labeling changes that strengthen the instruction regarding appropriate methods to be used when a physician experiences withdrawal resistance following stent deployment and balloon deflation. |
| P030032S001 10/13/04 Panel Track |
Hylaform Plus | Genzyme Biosurgery Cambridge, MA 02142 |
Approval for the Hylaform Plus. 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). |
| P030054/S003 10/25/04 Real-Time |
Epic™ HF CRT-D | St. Jude Medical, Inc. Sunnyvale, CA 94086 |
Approval for modifications to the design of the feedthrough assembly of the Epic HF device Model V-338 and minor modifications to provide consistency in the manufacturing process of Epic HF and Epic DR/VR ICDs. |
30-Day Notices (135 Day Supplement was not required)
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
| N17600/S021 10/29/04 |
Avitene Microfibrillar Collagen Hemostat Products and Avitene UltraFoam Cast Microfibrillar Collagen Hemostat Sponge | Davol, Inc. Cranston, RI 02920 |
Elimination and modification of the Endotoxin testing and modification of the lit seal strength testing and modification of the foil pouch seal strength testing. |
| P800002/S014 10/29/04 |
Avitene Microfibrillar Collagen Hemostat Products and Avitene UltraFoam Cast Microfibrillar Collagen Hemostat Sponge | Davol, Inc. Cranston, RI 02920 |
Elimination and modification of the Endotoxin testing and modification of the lit seal strength testing and modification of the foil pouch seal strength testing. |
| P940034/S016 10/8/04 |
GEN-PROBE® Amplified Mycobacterium Tuberculosis Direct Test | Gen-Probe, Inc. San Diego, CA 92121 |
Elimination of a specification for the control reagents that are no longer included as part of the MTD test kit. |
| D970012/S025 10/28/04 |
Model 700 Inflatable Penile Prosthesis | American Medical Systems, Inc. Minnetonka, MN 55343 |
Vendor changes for yarns used to produce tubular woven fabric and the use of an alternative yarn texturizer. |
| P020025/S007 10/12/04 |
EPT-1000XP Cardiac Ablation System | EP Technologies, Inc. San Jose, CA 95134 |
Elimination of a cleaning agent from the ring cleaning procedure and the implementation of a new automated UV curing fixture. |
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 25
Summary of PMA Originals Under Review
Total Under Review: 81
Total Active: 30
Total On Hold: 51
Number Greater Than 180 Days: 1
Summary of PMA Supplements Under Review
Total Under Review: 238
Total Active: 137
Total On Hold: 101
Number Greater Than 180 Days: 3
Summary of All PMA Submissions Received
Originals: 3
Supplements: 65
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 25
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 69.9
FDA Time: 54.2 Days
MFR Time: 15.7 Days
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