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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 WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS, ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910073
Supplement NumberS130
Date Received06/22/2015
Decision Date07/16/2015
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADD AN AUTOMATED VISION SYSTEM LABEL INSPECTION TO THE FINAL PACKAGING LINE, REMOVE REDUNDANT IN-PROCESS INSPECTION AND MOVE UPSTREAM VALIDATED INSPECTIONS TO A DOWNSTREAM STEP.
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