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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D
Generic Namecardiac resynchronization therapy
ApplicantMEDTRONIC CRDM
PMA NumberP010031
Supplement NumberS346
Date Received02/01/2013
Decision Date02/25/2013
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Update to the acceptance criterion for percent delamination on all die.
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