PMA supplement
P190023 S001: Portico Heart Valve, FlexNav Delivery System, FlexNav Loading System
FDA PMA supplement · Normal 180 Day Track No User Fee · ABBOTT MEDICAL
Key facts
| Original PMA | P190023 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | Portico Heart Valve, FlexNav Delivery System, FlexNav Loading System |
| Generic name | Aortic valve, prosthesis, percutaneously delivered |
| Applicant | ABBOTT MEDICAL |
| Product code | NPT |
| Received date | Oct 15, 2021 |
| Decision date | Nov 12, 2021 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: