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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 NameADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, RELIA IPG
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
ApplicantMEDTRONIC, INC.
PMA NumberP980035
Supplement NumberS304
Date Received01/22/2013
Decision Date02/07/2013
Product Code
NVZ
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Acceptance of an upgrade to test system software shell.
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