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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 SURESCAN PACING SYSTEM
Classification Nameimplantable pulse generator, pacemaker (non-crt)
ApplicantMEDTRONIC, INC
PMA NumberP090013
Supplement NumberS013
Date Received03/29/2011
Decision Date05/27/2011
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for model 2490g (version 9v5) medtronic carelink monitor and model 2491 device data management application (revo mri sw018 xmltu and enrhythm mri v7. 3 sw005 xmltu).
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