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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.
 
DeviceBRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S, VIVA QUAD XT,VIVA S, VIVA XT CR
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. NE
Mounds View, MN 55112
PMA NumberP010031
Supplement NumberS491
Date Received02/05/2015
Decision Date03/01/2015
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  
UPDATE THE FINAL VISUAL INSPECTION CRITERIA FOR THE HYBRIDS USED IN THE DEVICES.
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