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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 NameMEDTRONIC REVO MRI SURESCAN PACING SYSTEM
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Applicant MEDTRONIC INC.
PMA NumberP090013
Supplement NumberS022
Date Received05/04/2011
Decision Date05/26/2011
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 
Relocation of a sterilizer system within and existing location.
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