Micra Transcatheter Pacing System
FDA premarket approval P150033/S070 · decided 2020-06-17
Approval details
- PMA number
- P150033
- Supplement
- S070
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Micra Transcatheter Pacing System
- Generic name
- Leadless pacemaker
- Applicant
- Medtronic, Inc.
- Date received
- 2020-04-06
- Decision date
- 2020-06-17
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- PNJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval to pool existing usable M-PREP treadmill test data from the Micra IDE, China IDE, and the Micra rate response study.
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510(k) clearances by this applicant
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|---|---|---|
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| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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