PMA
P260007: Autus Size-Adjustable Valve
FDA PMA · Heart-valve, polymeric · Edwards Lifesciences, LLC
Key facts
| PMA number | P260007 |
|---|---|
| Trade name | Autus Size-Adjustable Valve |
| Generic name | Heart-valve, polymeric |
| Applicant | Edwards Lifesciences, LLC |
| Product code | SJL |
| Approval date | Oct 1, 2026 |
At a glance
- None Supplements
- Oct 1, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: