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 C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S020 |
Date Received | 05/10/1996 |
Decision Date | 05/15/1996 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ENDOTAK C LEAD (MODELS 0060, 0062, 0064, 0065, 0066, 0067, AND 0068), ENDOTAK SQ PATCH LEAD (MODEL 0047 AND 0063), ENDOTAK C LEAD (MODELS 0070, 0072, 0073, 0074, 0075, 0113, AND 0115), ENDOTAK SQ LEAD ARRAY (MODELS 0048 AND 0049), AND ENDOTAK DSP LEAD (MODELS 0092, 0093, 0094, 0095, 0096, 0097, 0123, AND 0125), WHICH REQUESTED APPROVAL TO ADD A PATIENT GROUP TO THE INDICATIONS FOR USE |
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