Aortic Valve, Prosthesis, Percutaneously Delivered
Basic Information
- Device Name
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Trade Name
- Evolut PRO+ System, Evolut FX System, Evolut FX+ System
- PMA Number
- P130021
- Supplement Number
- S174
- Device Class
- FDA Class 3
- Product Code
- NPT
- Generic Name
- Aortic valve, prosthesis, percutaneously delivered
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 27, 2025
- Date Received
- February 28, 2025
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 25M-3437
Advisory Committee Statement
Approval for the Evolut PRO+ System, Evolut FX System, Evolut FX+ System for expanding the indications to include the treatment of patients with a failed trascatheter aortic valve who are at high or greater risk of mortality from open surgical therapy. This device is indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality >8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator).
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NPT | Aortic Valve, Prosthesis, Percutaneously Delivered | FDA class 3 | Unknown |