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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.
 
DeviceMicra Transcatheter Pacing System (Micra AV/VR and Micra AV2/VR2)
Generic NameLeadless pacemaker
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP150033
Supplement NumberS212
Date Received06/17/2025
Decision Date08/15/2025
Product Code PNJ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for changes to the cybersecurity and adverse event information in the instructions for use for the Micra Transcatheter Pacing System.
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