Micra VR2 Transcatheter Pacing System, Micra AV2 Transcatheter Pacing System, Micra VR2/AV2 Application Software
FDA premarket approval P150033/S161 · decided 2023-04-20
Approval details
- PMA number
- P150033
- Supplement
- S161
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Micra VR2 Transcatheter Pacing System, Micra AV2 Transcatheter Pacing System, Micra VR2/AV2 Application Software
- Generic name
- Leadless pacemaker
- Applicant
- Medtronic, Inc.
- Date received
- 2022-11-04
- Decision date
- 2023-04-20
- Days to decision
- 167 days
- Decision code
- APPR
- Product code
- PNJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for two new models in the Micra Transcatheter Pacing System family, the Micra VR2 and the Micra AV2.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |