Identity
- Trade Name
- SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES FDA PMA
- Generic Name
- Aortic valve, prosthesis, percutaneously delivered FDA PMA
Identifiers
- PMA Number
- P140031 FDA PMA
- FDA Product Code
- NPT FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The SAPIEN 3 Transcatheter Heart Valve is a percutaneous aortic valve prosthesis designed for the relief of aortic stenosis. It is indicated for patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team to be at high or greater risk for open surgical therapy.
This device is supplied as a single-use implantable prosthesis and is delivered via transcatheter approach. It is authorized under FDA PMA (P140031) and is intended for use in clinical settings by trained medical professionals under the supervision of a heart team including a cardiac surgeon.
Frequently asked questions
What is the SAPIEN 3 Transcatheter Heart Valve used for?
The SAPIEN 3 Transcatheter Heart Valve is indicated for the relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy.
Is the SAPIEN 3 Transcatheter Heart Valve reusable?
No, the SAPIEN 3 Transcatheter Heart Valve is supplied as a single-use implantable prosthesis and is not intended for reuse.
What model number is associated with the SAPIEN 3 Transcatheter Heart Valve?
The SAPIEN 3 Transcatheter Heart Valve is specifically identified as Model 9600TFX in the authorization documentation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P140031 | Class III | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA PMA P140031 24 fields · synced Sep 18, 2026