Melody Transcatheter Pulmonary Valve System
FDA premarket approval P140017/S021 · decided 2022-03-01
Approval details
- PMA number
- P140017
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Melody 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
- Mounds View, MN
- 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.
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 |