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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/RELIA/ENRHYTHM/ADVISA DR/KAPPA 700/800/900/SIGMA/MEDTRONIC 350 IPG SERIES/ENPULSE/AT500 SYSTEMS IPGS
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
Applicant MEDTRONIC INC.
PMA NumberP980035
Supplement NumberS222
Date Received04/29/2011
Decision Date05/26/2011
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Update to process operation descriptions and the implementation of new test monitoring for packaging.
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