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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, ADVISA SR MRI IPG, APPLICATION SOFTWARE,AT500 DDDRP PACING
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
ApplicantMEDTRONIC, INC.
PMA NumberP980035
Supplement NumberS421
Date Received04/14/2015
Decision Date06/04/2015
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an upgrade to the bomgar server and addition of redundant remote control blocker software.
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