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. |
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Device | Micra AV TPS, Micra TPS |
Generic Name | Leadless pacemaker |
Regulation Number | 870.3610 |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P150033 |
Supplement Number | S166 |
Date Received | 03/21/2023 |
Decision Date | 06/07/2023 |
Product Code |
PNJ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for updating the current labeling of the Micra Transcatheter Pacing System (TPS) to include jugular venous access as an additional or alternate access site. |
Post-Approval Study | Show Report Schedule and Study Progress |
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