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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 CRT-D, VIVA S CRT-D, VIVA XT CRT-D
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP010031
Supplement NumberS428
Date Received02/18/2014
Decision Date03/05/2014
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE IN THE CRIMPING PROCESS FOR THE FEED THROUGH ASSEMBLY USED IN THE MANUFACTURE OF SELECTED IMPLANTABLE CARDIAC DEFIBRILLATORS (ICD) AND CARDIOVERTER RESYNCHRONIZATION THERAPY-DEFIBRILLATORS (CRT-D).
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