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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/SG LEAD MODELS 0180-0187
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP910073
Supplement NumberS043
Date Received12/04/2003
Decision Date03/02/2004
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDITION OF AN EPTFE COATING TO THE SHOCK COILS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENDOTAK RELIANCE G/SG LEAD MODELS AND IS INDICATED FOR PROVIDING PACING AND RATE-SENSING AND TO DELIVER CARDIOVERSION AND DEFIBRILLATION SHOCKS FOR ICD AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS.
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