Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | VENTAK(R) P MODEL 1600 |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P890061 |
Supplement Number | S010 |
Date Received | 04/06/1995 |
Decision Date | 11/20/1995 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ALTERNATE MANUFACTURING SITE FOR ASSEMBLY OF THE EXTERNAL PRODUCTS (PROGRAMMERS, SOFTWARE MODULES/DISKS, EXTERNAL COARDIOVERTER DEFIBRILLATORS, AND RELATED ACCESSORIES) WHICH ARE USED WITH CPI PACEMAKER AND AICD SYSTEMS. THE PROPOSED ALTERNATE MANUFACTURING SITE (CARDIGAN FACILITY) IS LOCATED AT THE FOLLOWING ADDRESS: CPI CARDIAGAN FACILITY, 599 CARDIGAN ROAD, SHOREVIEW, MINNESOTA 55126 |
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