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 | ENDOTAK(R) LEAD SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S015 |
Date Received | 05/01/1995 |
Decision Date | 11/27/1995 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE DECREASE IN THE LEAD BODY DIAMETER TO BE A MAXIMUM DIAMETER OF 10 FRENCH AND MODIFICATIONS IN THE LEAD COMPONENTS - THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENDOTAK DSP LEAD MODELS 0092, 0093, 0094, 0095, 0096, 0097, 0123, AND 0125 |
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