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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.
 
DeviceHV SPLITTER/ADAPTOR KIT, SPRINT QUATTRO LEAD, 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 NumberS161
Date Received07/14/2015
Decision Date07/28/2015
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  
CHANGE TO THE LOCATION OF THE SUPPLIER OF THE LEAD INNER TRAY AND TO ADD VENTING CHANNELS TO THE INNER TRAY PACKAGE FOR THE DEVICES.
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