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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 NumberS357
Date Received02/07/2013
Decision Date03/07/2013
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Multiple manufacturing changes previously accepted for other market released medtronic devices, which included: 1) cmos process flow changes at your supplier; 2) updates to the test software and hardware for integrated circuits; 3) addition of high temperature monitoring to the high power lean line; 4) update to a manufacturing assembly controller system; 5) implementation of a new cleaning process and curing oven; and 6) and implementation of the manufacturing execution system version 7. 9 at various internal suppliers and final device manufacturing locations.