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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 AV TPS
Generic NameLeadless pacemaker
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP150033
Supplement NumberS078
Date Received07/02/2020
Decision Date07/30/2020
Product Code PNJ 
Advisory Committee Cardiovascular
Clinical TrialsNCT03752151
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 to add Quality of Life surveys at select study sites for the post-approval study (PAS) protocol.
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