PMA
P150011: PERCEVAL SUTURELESS HEART VALVE
FDA PMA · Heart-valve, non-allograft tissue · Corcym S.r.l.
Key facts
| PMA number | P150011 |
|---|---|
| Trade name | PERCEVAL SUTURELESS HEART VALVE |
| Generic name | Heart-valve, non-allograft tissue |
| Applicant | Corcym S.r.l. |
| Owner/operator | Corcym Canada Corp. |
| Product code | LWR |
| Approval date | Jan 8, 2016 |
| Docket number | 16M-0123 |
| Notice date | Jan 11, 2016 |
| Establishment registration | 3004478276 |
| FEI number | 3004478276 |
At a glance
- 10–99 Supplements
- Dec 22, 2025 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- No Withdrawn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: