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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.
 
DeviceACE HEADER, DEFIBRILLATION SUPPORT DEVICE (DISD), END CAP, EPICARDIAL PATCH LEAD, SIZING SLEEVE, UPSIZING SLEEVE
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP900061
Supplement NumberS118
Date Received11/21/2012
Decision Date12/20/2012
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
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