MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM
FDA premarket approval P150033 · decided 2016-04-06
Approval details
- PMA number
- P150033
- Trade name
- MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM
- Generic name
- Leadless pacemaker
- Applicant
- Medtronic, Inc.
- Date received
- 2015-09-17
- Decision date
- 2016-04-06
- Days to decision
- 202 days
- Decision code
- APPR
- Product code
- PNJ
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- Mounds View, MN
- Statement
- Approval for the Micra Transcatheter Pacemaker System (Pacemaker Model MC1VR01 and Programmer Application Software model SW022 Version 1.1). This device is indicated for use in patients who have experienced one or more of the following conditions: symptomatic paroxysmal or permanent high-grade AV block in the presence of AF symptomatic paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual chamber pacing, when atrial lead placement is considered difficult,
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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 |