|
Device | Micra Transcatheter Pacemaker System, Micra Transcatheter Pacemaker System, Micra AV application software |
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 | S105 |
Date Received | 04/23/2021 |
Decision Date | 05/21/2021 |
Product Code |
PNJ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for additional verification of the date of manufacture and use by date for devices undergoing rework activities. |