PMA
P130011: FREEDOM SOLO STENTLESS HEART VALVE
FDA PMA · Heart-valve, non-allograft tissue · Corcym Canada Corp
Key facts
| PMA number | P130011 |
|---|---|
| Trade name | FREEDOM SOLO STENTLESS HEART VALVE |
| Generic name | Heart-valve, non-allograft tissue |
| Applicant | Corcym Canada Corp |
| Owner/operator | Corcym Canada Corp. |
| Product code | LWR |
| Approval date | Jun 24, 2014 |
| Docket number | 14M-1064 |
| Notice date | Jul 23, 2014 |
| Establishment registration | 3004478276 |
| FEI number | 3004478276 |
At a glance
- 10–99 Supplements
- Jul 28, 2022 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: