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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 QUAD CRT-D, VIVA QUAD C CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D
Generic Namecardiac resynchronization therapy
ApplicantMEDTRONIC, INC.
PMA NumberP010031
Supplement NumberS458
Date Received07/31/2014
Decision Date08/12/2014
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of fill hole seal laser welding equipment.
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