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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 IS-1 FAMILY OF LEADS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910073
Supplement NumberS089
Date Received10/29/2010
Decision Date06/14/2011
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ACCEPTANCE OF AN ENHANCEMENT TO THE INSULATION AND TRI-LUMEN BOND PROCESS, TO INCLUDE AN UPGRADE OF THE BONDING EQUIPMENT AND ADDITIONAL ACCEPTANCE ACTIVITY INSPECTIONS TO VERIFY AN ADEQUATE BOND WHICH WILL PREVENT FLUID LEAKAGE.
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