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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
Generic NameLeadless pacemaker
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP150033
Supplement NumberS225
Date Received03/20/2026
Decision Date04/22/2026
Product Code PNJ 
Advisory Committee Cardiovascular
Clinical TrialsNCT02004873
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of protocol changes for the post-approval study (PAS) referenced above
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