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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.
 
DeviceY ADAPTOR EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, IS-1 CIONNECTIR PORT PIN PLUG, LEAD ADAPTOR, SPRINT QUATTRO LEAD
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP920015
Supplement NumberS123
Date Received10/30/2013
Decision Date11/26/2013
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
REDUCE THE EXPOSURE TIME DURING ETHYLENE-OXIDE HALF-CYCLE TESTING.
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