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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.
 
DeviceRELIANCE FAMILY ACTIVE FIXATION TACHY LEADS
Generic NamePermanent defibrillator electrodes
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP910073
Supplement NumberS075
Date Received09/12/2008
Decision Date11/07/2008
Product Code NVY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR A LUMEN SEAL MODIFICATION ON ENDOTAK RELIANCE, RELIANCE S, RELIANCE G, AND RELIANCE SG LEAD FAMILIES.
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