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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,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D
Generic Namecardiac resynchronization therapy
ApplicantMEDTRONIC, INC.
PMA NumberP010031
Supplement NumberS431
Date Received03/07/2014
Decision Date04/04/2014
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing process change for the printed wiring board (pwb) substrates at a medtronic second tier supplier. These pwb substrates are used in the manufacture of hybrid substrates at medtronic¿s internal supplier, medtronic tempe campus (mtc), for the devices.
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