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Device | ENDOTAK ENDURANCE RX ENDOCARDIAL DEFIBRILLATION LEADS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S025 |
Date Received | 07/30/1998 |
Decision Date | 01/27/1999 |
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 Models 0144, 0145 and 0146 endocardial defibrillation leads. The device, as modified, will be marketed under the trade name ENDOTAK(R) ENDURANCE (Rx(TM)) Endocardial Defibrillation Lead and is indicated for use to provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for VENTAK AICD automatic implantable cardioverter defibrillator systems. |