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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.
Generic Namecardiac resynchronization therapy
PMA NumberP010031
Supplement NumberS356
Date Received02/07/2013
Decision Date03/05/2013
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
(1) factory works release 8. 0 and mes web services release 2. 1; (2) modification of controlled environment area; (3) new pressure tester at smo facility; and (4) temporary gowning area and temporary walls and relocation of the milling room.