Portico Transcatheter Aortic Valve Implantation System

FDA premarket approval P190023 · decided 2021-09-17

Approval details

PMA number

P190023

Trade name

Portico Transcatheter Aortic Valve Implantation System

Generic name

Aortic valve, prosthesis, percutaneously delivered

Applicant

ABBOTT MEDICAL

Date received

2019-09-09

Decision date

2021-09-17

Days to decision

739 days

Decision code

APPR

Product code

NPT

Advisory committee

Cardiovascular

Expedited review

No

Location

St. Paul, MN

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

510(k) clearances by this applicant