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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 NameREVO MRI IPG
Classification Nameimplantable pulse generator, pacemaker (non-crt)
ApplicantMEDTRONIC, INC.
PMA NumberP090013
Supplement NumberS140
Date Received04/25/2014
Decision Date05/15/2014
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Antenna wire bond coat manufacturing standardization for the devices.
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