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Device | ENDOTAK FAMILY OF ENDOCARDIAL DEFIBRILLATION LEAD MODELS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S027 |
Date Received | 07/26/1999 |
Decision Date | 09/29/1999 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a modified DF-1 terminal of the ENDOTAK(R) series of Endocardial Defibrillation Leads and the Model 6952 Lead Extender, which consists of a shorter terminal pin, a counter bore in the terminal pin, and a modified coil transition. |