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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 OF LEADS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
BOSTON SCIENTIFIC
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP910073
Supplement NumberS068
Date Received11/13/2007
Decision Date12/19/2007
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE TO: 1) THE PACKAGING LOCATION FROM AVID MEDICAL TO CODMAN & SHURTLEFF, INC.; 2) THE PACKAGING COMPONENT SUPPLIERS; AND 3) THE TOUHY NEEDLES AND RULER SUPPLIERS.
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