Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
FDA PMAUnclassified (US FDA PMA)
Identity
- Trade Name
- Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System FDA PMA
- Generic Name
- Pulmonary valve prosthesis percutaneously delivered FDA PMA
Identifiers
- PMA Number
- P200015 FDA PMA
- FDA Product Code
- NPV FDA PMA
Classification
- Device Class
- Unclassified FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Edwards SAPIEN 3 Transcatheter Heart Valve System with Commander Delivery System is a pulmonary valve prosthesis percutaneously delivered, classified under the OpenFDA nomenclature as a transcatheter valve. It is designed to address dysfunction in the right ventricular outflow tract (RVOT) conduit or surgical bioprosthetic valve in the pulmonic position, providing a minimally invasive alternative for patients with moderate or severe regurgitation or elevated mean gradients (≥35 mmHg).
This system is intended for use in pediatric and adult patients requiring intervention for RVOT dysfunction. It is supplied as a sterile, single-use device, delivered via the Edwards Commander Delivery System, and is authorized under FDA_PMA (PMA Number: P200015). The device is intended for percutaneous implantation and is not intended for MRI compatibility or reuse. Storage and handling must comply with sterile medical device protocols as specified by the manufacturer.
Frequently asked questions
What types of patients is the Edwards SAPIEN 3 Transcatheter Heart Valve System intended for, and what conditions does it treat?
The Edwards SAPIEN 3 Transcatheter Heart Valve System is intended for pediatric and adult patients who require intervention for dysfunction in the right ventricular outflow tract (RVOT), specifically in cases involving a dysfunctional RVOT conduit or surgical bioprosthetic valve in the pulmonic position. It is designed to address moderate or severe regurgitation and/or elevated mean gradients (≥35 mmHg) in these structures, offering a minimally invasive alternative to traditional surgical options.
Is the Edwards SAPIEN 3 Transcatheter Heart Valve System reusable, and what are the storage requirements?
The Edwards SAPIEN 3 Transcatheter Heart Valve System is a single-use device and must not be reused. Due to its sterile nature, storage and handling must strictly adhere to sterile medical device protocols as outlined by the manufacturer to ensure safety and efficacy.
How is the Edwards SAPIEN 3 Transcatheter Heart Valve System delivered, and what are its key features?
The device is percutaneously delivered via the Edwards Commander Delivery System, allowing for minimally invasive implantation. It is specifically designed as a pulmonary valve prosthesis to address dysfunction in the RVOT conduit or pulmonic surgical bioprosthetic valve, providing a solution for moderate or severe regurgitation or elevated gradients (≥35 mmHg).
What regulatory pathway was followed for the approval of this device, and what does that mean for its use?
The Edwards SAPIEN 3 Transcatheter Heart Valve System received FDA approval through the Premarket Approval (PMA) process, indicated by the PMA Number P200015. This means the device has undergone rigorous review by the FDA to ensure its safety and effectiveness for its intended use in managing dysfunctional RVOT conduits or pulmonic surgical bioprosthetic valves in patients with moderate or severe regurgitation or elevated gradients.
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. Sources consulted: Edwards Lifesciences – the leading global structural heart innovation ..., Transcatheter SAPIEN 3 | Edwards Lifesciences, SAPIEN 3 transcatheter heart valve - Edwards Lifesciences, Produkte - Edwards Vacuum - Deutschland
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P200015 | Unclassified | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA PMA P200015 24 fields · synced Sep 18, 2026