Harmony Transcatheter Pulmonary Valve System
FDA premarket approval P200046/S007 · decided 2022-03-01
Approval details
- PMA number
- P200046
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Harmony Transcatheter Pulmonary Valve System
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Applicant
- Medtronic, Inc.
- Date received
- 2022-02-28
- Decision date
- 2022-03-01
- Days to decision
- 1 days
- Decision code
- OK30
- Product code
- NPV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Use of a new data management system for microbiology laboratory test data and data reporting at the Medtronic Tijuana facility for the Evolut R, Evolut PRO, Evolut PRO+, and Evolut FX Transcatheter Aortic Valves (TAVs), Harmony and Melody Transcatheter Pulmonic Valves (TPV), and Avalus bioprosthesis products.
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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 |