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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceENDOTAK RELIANCE G AND SG ENDOCARDIAL DEFIBRILLATION LEAD
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP910073
Supplement NumberS041
Date Received03/04/2003
Decision Date11/04/2003
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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