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 RELIANCE G AND SG ENDOCARDIAL DEFIBRILLATION LEAD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S041 |
Date Received | 03/04/2003 |
Decision Date | 11/04/2003 |
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 TO MODIFY THE ACTIVE AND PASSIVE FIXATION ENDOTAK FAMILY OF DEFIBRILLATION LEADS AND TO PACKAGE THE LEADS WITH A TRANSVALVULAR INSERTION TOOL FOR USE WITH A HEMOSTATIC INTRODUCER. THE LEADS, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENDOTAK RELIANCE G ENDOCARDIAL DEFIBRILLATION LEAD, MODELS 0164, 0165, 0166, 0167, 0174, 0175, 0176, 0177 AND ENDOTAK RELIANCE SG ENDOCARDIAL DEFIBRILLATION LEAD, MODELS 0160, 0161, 0162, 0163. |
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