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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.
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP980035
Supplement NumberS308
Date Received02/07/2013
Decision Date03/07/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
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.