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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 NumberS090
Date Received03/27/2013
Decision Date04/11/2013
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Reduction of the hybrid burn-in time for the advisa dr, advisa dr mri ipgs, revo mri ipg, consulta and syncra crt-ps.
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