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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, Micra TPS
Generic NameLeadless pacemaker
Regulation Number870.3610
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP150033
Supplement NumberS104
Date Received04/07/2021
Decision Date06/17/2021
Product Code PNJ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for minor design changes to the endcap assembly used in the Micra and Micra AV Transcatheter Pacing Systems.
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