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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceREVO MRI IPG, RVDR01
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
Medtronic, Inc
8200 coral sea street ne
mounds view, MN 55112
PMA NumberP090013
Supplement NumberS068
Date Received07/25/2012
Decision Date08/17/2012
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
NEW PRESSURE TEST EQUIPMENT USED TO VERIFY HERMETICITY.
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