Portico Transcatheter Aortic Valve Implantation System

FDA Premarket Approval P190023

Pre-market Approval Supplement Details

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).

DevicePortico Transcatheter Aortic Valve Implantation System
Generic NameAortic Valve, Prosthesis, Percutaneously Delivered
ApplicantAbbott
Date Received2019-09-09
Decision Date2021-09-17
PMAP190023
SupplementS
Product CodeNPT 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address Abbott one St. Jude Medical Drive st. Paul, MN 55117

Supplemental Filings

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Supplement NumberDateSupplement Type
P190023Original Filing

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