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 | S024 |
Date Received | 02/19/1998 |
Decision Date | 08/13/1998 |
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 a design change to provide higher pacing impedance. Teh device, as modified, will be marketed under the trade name ENDOTAK(R) Endurance(TM) Endocardial Defibrillation Lead and is indicated for use to provide pacing and rate-sensing and delivery cardioversiona nd defibrillation shocks for AICD automatic implantable cardioverter defibrillator systems. |
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