Home › Device types › NPV
Pulmonary Valve Prosthesis Percutaneously Delivered
FDA product code NPV · Class f · Unknown
39
Registered devices
2,280
Adverse events
2
Recalls
0
510(k) clearances
Devices with this code
Edwards SAPIEN 3 transcatheter pulmonic valve delivery system — Edwards Lifesciences LLCTHE EDWARDS SAPIEN 3 VALVE WITH ALTERRA ADAPTIVE PRESTENT SYSTEM — Edwards Lifesciences LLCHarmony™ — MEDTRONIC, INC.Ensemble™ — MEDTRONIC, INC.ENSEMBLE™ — MEDTRONIC, INC.Melody™ TPV — MEDTRONIC, INC.Edwards SAPIEN 3 transcatheter pulmonic valve delivery system — Edwards Lifesciences LLCENSEMBLE™ — MEDTRONIC, INC.EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) — Edwards Lifesciences LLCContegra® — MEDTRONIC, INC.EDWARDS COMMANDER DELIVERY SYSTEM — Edwards Lifesciences LLCEnsemble™ — MEDTRONIC, INC.EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) — Edwards Lifesciences LLCEDWARDS COMMANDER DELIVERY SYSTEM — Edwards Lifesciences LLCEDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) — Edwards Lifesciences LLCENSEMBLE™ — MEDTRONIC, INC.EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) — Edwards Lifesciences LLCEnsemble™ ll — MEDTRONIC, INC.Harmony™ — MEDTRONIC, INC.Edwards SAPIEN 3 transcatheter pulmonic valve delivery system — Edwards Lifesciences LLCEDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) — Edwards Lifesciences LLCContegra® — MEDTRONIC, INC.Ensemble™ — MEDTRONIC, INC.ENSEMBLE™ — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-22 | Medtronic Heart Valves Division | Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system un |
| 2022-03-02 | Medtronic Inc | There is potential for the capsule bond to break during the procedure. |
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