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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 NameVIVA XT CRT-D, VIVA S CRT-D, BRAVA CRT-D, VIVA/BRAVA/EVERA SOFTWARE APPLICATION
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS318
Date Received07/05/2012
Decision Date01/29/2013
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Clinical Trials NCT00980057
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the viva/brava implantable cardioverter defibrillators with cardiac resynchronization (crt-d).
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