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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 Ave. N
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
Predetermined Change Control Plan AuthorizedNo
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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