PMA P130021S174

Device: Evolut PRO+ System, Evolut FX System, Evolut FX+ System
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S174
Product code: NPT
Decision date: 2025-08-27
Classification: Cardiovascular
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order 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).

Current openFDA PMA Record#

Device: Evolut PRO+ System, Evolut FX System, Evolut FX+ System
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S174
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2025-08-27
Decision code: APPR
Date received: 2025-02-28
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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).