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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 SR MRI IPG AND ADVISA DR MRI IPG
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
ApplicantMEDTRONIC, INC.
PMA NumberP980035
Supplement NumberS420
Date Received03/26/2015
Decision Date05/27/2015
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of a change to the electronic module assembly specification.
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