PMA
P190023: Portico Transcatheter Aortic Valve Implantation System
FDA PMA · Aortic valve, prosthesis, percutaneously delivered · ABBOTT MEDICAL
Key facts
| PMA number | P190023 |
|---|---|
| Trade name | Portico Transcatheter Aortic Valve Implantation System |
| Generic name | Aortic valve, prosthesis, percutaneously delivered |
| Applicant | ABBOTT MEDICAL |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | NPT |
| Approval date | Sep 17, 2021 |
| Docket number | 21M-1010 |
| Notice date | Sep 10, 2021 |
| Establishment registration | 3007113487 |
| FEI number | 3007113487 |
At a glance
- 10–99 Supplements
- Jul 9, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: