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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.
 
DeviceMYCARELINK PATIENT MONITOR
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP890003
Supplement NumberS280
Date Received07/08/2013
Decision Date09/27/2013
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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