Portico Transcatheter Aortic Valve Implantation System
FDA premarket approval P190023 · Aortic valve, prosthesis, percutaneously delivered
PMA numberP190023
Approval
- Applicant
- Abbott Medical
- Received
- September 9, 2019
- Decision date
- September 17, 2021 (APPR)
- Supplements
- 32, latest July 9, 2026
- Product code
- NPT – Aortic Valve, Prosthesis, Percutaneously Delivered
Approval order statement
Approval for the Portico Transcatheter Aortic Valve Implantation System. The device is indicated for 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 (i.e., predicted risk of surgical mortality >= 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).