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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
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea St. NE
Mounds View, MN 55112
PMA NumberP090013
Supplement NumberS107
Date Received07/08/2013
Decision Date09/27/2013
Product Codes LWP NVN 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR THE MYCARELINK PATIENT MONITOR MODELS 24950 (SOFTWARE VERSION R50), 24951 (SOFTWARE VERSION R50.A.1), AND 24955 (SOFTWARE VERSION V29) TO BE USED WITH THE DEVICES.
Approval OrderApproval Order
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