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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, ADVISA DR MRI IPG
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
Applicant MEDTRONIC INC.
PMA NumberP980035
Supplement NumberS370
Date Received03/20/2014
Decision Date04/15/2014
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
New equipment in the final packaging lines at the medtronic puerto rico operations company.
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