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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.
 
DeviceADVISA DR
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Applicant
MEDTRONIC Inc.
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP980035
Supplement NumberS260
Date Received02/13/2012
Decision Date03/09/2012
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 
Add additional models that were not included in a previously approved 30-day notice regarding the implementation of material analysis and qualification system (maqs) for incoming inspection.
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