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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 NameADVISA DR IPG, ADVISA DR MRI IPG
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
Applicant MEDTRONIC INC.
PMA NumberP980035
Supplement NumberS375
Date Received04/25/2014
Decision Date05/15/2014
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Antenna wire bond coat manufacturing standardization for the devices.
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