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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, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D
ApplicantMEDTRONIC, INC.
PMA NumberP010031
Supplement NumberS498
Date Received03/03/2015
Decision Date03/19/2015
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Merging two different electrical connector monitoring plans to establish one standard plan used for both the battery and capacitor electrical connectors.
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