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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 Application Software
Generic NameLeadless pacemaker
Regulation Number870.3610
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP150033
Supplement NumberS061
Date Received10/29/2019
Decision Date01/15/2020
Product Code PNJ 
Advisory Committee Cardiovascular
Clinical TrialsNCT03752151
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Micra AV Transcatheter Pacing System Model MC1AVR1 and Application Software Model SW044.
Post-Approval StudyShow Report Schedule and Study Progress
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