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PMA Final Decisions Rendered for October 1999 |
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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 |
|
10/25/99 |
PepGen P-15 |
CeraMed Corporation San Francisco, CA 94105-1635 |
Approval for PepGen P-15. This device is intended to be used for intrabony periodontal osseous defects due to moderate or severe periodontitis. |
| PMA Supplemental Approvals | |||
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|
N50510/S094 10/7/99 |
Vitek® 2 Gram Negative Susceptibility Test for Amikacin |
BioMerieux, Inc. Hazelwood, MI 63042-2320 |
Approval for the addition of the antibiotic Amikacin at concentrations of 8, 16 and 64 m g/ml to the Vitek® 2 Gram Negative Susceptibility Test System. The device is indicated for use in Vitek® 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to amikacin in the range of £ 2 to ³ 64 m g/ml. |
|
P810002/S045 10/21/99 |
St. Jude Medical Mechanical Heart Valve |
St. Jude Medical, Inc. St. Paul, MN 55117 |
Approval for an increase of the orifice lot sizes during the pyrolytic carbon coating process at the Woodrige manufacturing facility. |
|
P830026/S076* 10/29/99 |
Rx5000 Pacemaker Programmers |
Guidant Cardiac Rhythm Management St. Paul, MN 55112-5798 |
Approval for a modification to the as shipped configuration for refurbished and repaired Rx5000 Pacemaker Programmers. Specifically, to offer the Triangular Chest Lead Cable Model 526-04 as a purchasable accessory and no longer include it with the shipped units. |
|
P830039/S010 10/29/99 |
Omniscience® Cardiac Valve |
Medical, Inc. Inner Grove Heights, MN 55077 |
Approval for modifications to the Omni-Series Instructions for Handling and Use. |
|
P830055/S064* 10/4/99 |
LCS Total Knee System |
DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for a line extension consisting of the addition of LCS Revision System components include LCS cemented revision femoral, tibial tray, and augment components. The stems of the LCS revision tibial tray and femoral components are designed to allow for the use of ancillary stem extensions and sleeves from cleared and currently marketed devices. The device is indicated for the cemented revision of failed knee prostheses. |
|
P830055/S065* 10/7/99 |
LCS Total Knee System |
DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for a modification to the LCS Polyethylene Three-Pegged Patellar Component of the LCS Total Knee System. The current modification reduces the thickness of the three-pegged polyethylene patellar components by approximately two millimeters. |
|
P830055/S066* 10/7/99 |
LCS Total Knee System |
DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for a design modification to the LCS PS (Posterior Stabilized) Tibial Inserts of the LCS Total Knee System. The proposed modifications to the PS Tibial Inserts include a reduction in the height of the anterior lip and a change in the medial/lateral angle of the tibial spine. |
|
P850064/S016 10/5/99 |
Life Pulse High Frequency Ventilator |
Bunnell Inc. Salt Lake City, UT 84115 |
Approval for the addition of three warnings. |
|
P860004/S043* 10/29/99 |
Medtronic® Model 8711 Two Piece Intrathecal Catheter |
Medtronic, Inc. Shoreview, MN 55126-2983 |
Approval for a design change to the Model 8703W intraspinal catheter. The resulting catheter incorporates the same materials and basic design as Model 8703W except for a closed distal tip with six side holes instead of a single open tip. The device, as modified, will be marketed under the trade name Medtronic® Model 8711 Two Piece Intrathecal Catheter and is indicated for the containment and delivery of parenteral drugs to the intrathecal space of the spinal cord. |
|
P890055/S011* 10/25/99 |
Arrow Model 3000/ 3000-16/3000-50 Implantable Infusion Pump |
Therex Corporation Walpole, MA 02081 |
Approval for the following modifications: 1) Increasing the Flex Tip Plus Intraspinal Catheter length; 2) Combining the infusion pump and the approved refill kit to facilitate the pump pre-implant procedure; 3) Adding a thermometer to the packaging for the monitoring of water bath temperature; and 4) Adding an informational chart of drug solution to the labeling. |
|
P900056/S029 10/15/99 |
Rotablator® Rotational Angioplasty System |
Boston Scientific Corporation Redmond, WA |
Approval for labeling changes to the Instructions for Use for the Rotablator System. |
|
P910018/S001 10/29/99 |
Liposorber® LA-15 System |
Kaneka Pharma America Corp. New York, NY 10022 |
Approval for the following changes: 1) replacing the Membrane Filter Unit (MFU) located in the Liposorber LA-15 adsorption column, with the Cardioplegia Supor-1220 filter, which is bonded to the Extracoporeal Blood Tubing System, LT-MA2; 2) removing the maintenance unit and adding a clamp valve cover plate to the MA-01 Apheresis Unit; 3) making nine software changes, most of which are intended to either simplify procedures, ease the display of treatment parameters, or to make the therapy safer for the patients; and, 4) revising the Operators' Manual to incorporate the revisions associated with the hardware and software changes. |
|
P910023/S044 10/13/99 |
Cadence® Tiered-Therapy Defibrillator System |
St. Jude Medical Sunnyvale, CA 94086-6527 |
Approval for an alternate manufacturing site for accessories and the DP-3238 Defibrillation Patch Lead located at St. Jude Medical, Cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar, CA 91342-3577. |
|
10/21/99 |
SVS Apex Plus Excimer Laser Workstation, emphasis® discs K and L, and axicon |
Summit Technology, Inc. Waltham, MA 02154 |
Approval for the SVS Apex Plus Excimer Laser Workstation, emphasis® discs K and L, and axicon. These devices are indicated to perform hyperopic PRK. |
|
10/21/99 |
SVS Apex Plus Excimer Laser Workstation and emphasis® "M" discs |
Summit Technology, Inc. Waltham, MA 02154 |
Approval for the SVS Apex Plus Excimer Laser Workstation and emphasis® "M" discs (M00-M09) These devices are indicated to perform LASIK: 1) for the reduction or elimination of myopia ranging from 0.0 to –14.0 diopters (D) with or without astigmatism ranging from -0.5D to -5.0D; 2) in patients 18 years of age or older; and 3) in patients with documentation of a stable manifest refraction (± 0.5D) over the past year. |
|
P940031/S020* 10/22/99 |
Pulsarmax™ Pacemakers, Models 1170, 1171, 1270/Pulsar™ pacemakers models 470, 970, 972, 1172, 1272/Discovery™ Pacemakers Models 1174, 1175, 1273, 1274, 1275/Meridian™ Pulse Generators Models 476, 976, 1176 and 1276 |
Guidant Corporation St. Paul, MN 55112-5798 |
Approval for addition of a non-conducting epoxy preform between layers of the "triple stack". |
|
P940031/S021* 10/20/99 |
Pulsar/Discovery/ Meridian (PDM) pacemakers with Software Application Model 2890 Revision 3.27 |
Guidant Corporation St. Paul, MN 55112-5798 |
Approval for Software Application Model 2890 Revision 3.27 which removes automatic Minute Ventilation (MV) initialization, adds a "pop-up" warning on the programmer screen prior to manual MV initialization, and corrects several minor anomalies applicable to the entire PDM pacemaker line. |
|
P950018/S003 10/12/99 |
Perfluoron |
Alcon Laboratories, Inc. Fort Worth, TX 76134-2099 |
Approval for a manufacturing site located at Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth, Texas 76134-2099. |
|
P950019/S008 10/4/99 |
Ray Threaded Fusion Cage (TFC)™ with instrumentation |
United States Surgical Corporation Norwalk, CT 06856 |
Approval for the Ray TFC™ Unite Device, a modified version of the approved Ray TFC™. |
|
P950032/S014* 10/14/99 |
Apligraf (Graftskin) |
Organogenesis, Inc. Canton, MA 02021 |
Approval to introduce a new cell strain into the production of Apligraf (i.e., HEP 601). |
|
P960004/S007** 10/21/99 |
ThinLine™ Models 430-10, 432-04, ThinLine™ EZ Model 438-10 and FINELINE™ Models 4450, 4451, 4460, 4461, 4462, 4475, and 4476 Endocardial Pacing Leads |
Guidant Corporation St. Paul, MN 55112 |
Approval for a manufacturing process change. |
|
P970058/S005* 10/5/99 |
ImageChecker M1000 |
R2 Technology, Inc. Los Altos, CA 94022 |
Approval for the addition of the Canon Model 300 digitizer as an optional digitizer for the ImageChecker M1000. |
|
P990017/S001 10/20/99 |
ANCURE Tube and Bifurcated Systems and ANCURE Iliac Balloon Catheter |
Guidant Corporation Menlo Park, CA 94025 |
Approval for a new manufacturing facility located at Guidant Corporation, 1525 O'Brien Drive, Menlo Park, CA. |
| 30-Day Notices (***135 Day Supplement was not required) | |||
| APPLICATION NUMBER & LTR DATE | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | COMMENTS |
|
P860057/S012*** 10/22/99 |
Carpentier-Edwards® Bioprosthetic Heart Valves, Various Models |
Cardiovascular Group Santa Ana, CA 92711-1150 |
The 30-Day Notice proposed a change in the quality control tests used to declare sterility of finished bioprosthetic heart valves. The change will allow for parametric release following terminal liquid sterilization in accordance with Documentation and Release Criteria for Liquid Chemical Sterilization Process. |
|
P870056/S012*** 10/22/99 |
Carpentier-Edwards® Bioprosthetic Heart Valves, Various Models |
Cardiovascular Group Santa Ana, CA 92711-1150 |
The 30-Day Notice proposed a change in the quality control tests used to declare sterility of finished bioprosthetic heart valves. The change will allow for parametric release following terminal liquid sterilization in accordance with Documentation and Release Criteria for Liquid Chemical Sterilization Process. |
|
P870077/S010*** 10/22/99 |
Carpentier-Edwards® Bioprosthetic Heart Valves, Various Models |
Cardiovascular Group Santa Ana, CA 92711-1150 |
The 30-Day Notice proposed a change in the quality control tests used to declare sterility of finished bioprosthetic heart valves. The change will allow for parametric release following terminal liquid sterilization in accordance with Documentation and Release Criteria for Liquid Chemical Sterilization Process. |
|
P890043/S034*** 10/12/99 |
Simpson Coronary AtheroCath-GTO®/Simpson Coronary AtheroCath-BANTAM™ |
Guidant Corporation Temecula, CA 92591-4628 |
The 30-Day Notice requested implementation of two additional on-line inspections to the current manufacturing process to provide added assurance that the manufacturing step for attaching the nose cone to the housing has been performed correctly. |
|
P920004/S011*** 10/22/99 |
VasoSeal® (Vascular Hemostasis Device) |
Datascope Corporation Montvale, NJ 07645 |
The 30-Day Notice proposed a change in the quality control tests used to Declare sterility of the VasoSeal® Needle Depth Indicator Kit. The change will allow for dosimetric release following gamma radiation sterilization in accordance with ANSI/AAMI/ISO 11137-1995 Requirements for validation and routine control – Radiation sterilization. |
|
P810046/S199*** 10/29/99 |
ACS OTW Photon™ Coronary Dilatation Catheter |
Guidant Corporation Temecula, CA 92591-4628 |
The 30-Day Notice requested: 1) modification of the manufacturing process by which the proximal adapter is bonded to the proximal portion of the ACS OTW PHOTON™ Coronary Dilatation Catheter; and 2) modification of the adaptation tensile test at the finished device audit process. |
*Real-Time Review Supplement
**135 Day Supplement
***A 135 Day Supplement Was Not Required
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 23
Summary of PMA Originals Under Review
Total Under Review: 91
Total Active: 52
Total On Hold: 39
Number Greater Than 180 Days: 1
Summary of PMA Supplements Under Review
Total Under Review: 253
Total Active: 168
Total On Hold: 85
Number Greater Than 180 Days: 5
Summary of All PMA Submissions Received
Originals: 14
Supplements: 84
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 23
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 131
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