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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 NumberS012
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 - software
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for software application sw005 version 7. 3 for carelink model 2090 programmer.
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