PMA
P060038: MITROFLOW AORTIC PERICARDIAL HEART VALVE
FDA PMA · Heart-valve, non-allograft tissue · Corcym Canada Corp
Key facts
| PMA number | P060038 |
|---|---|
| Trade name | MITROFLOW AORTIC PERICARDIAL HEART VALVE |
| Generic name | Heart-valve, non-allograft tissue |
| Applicant | Corcym Canada Corp |
| Owner/operator | Corcym Canada Corp. |
| Product code | LWR |
| Approval date | Oct 23, 2007 |
| Docket number | 07M-0410 |
| Notice date | Nov 9, 2007 |
| Establishment registration | 3004478276 |
| FEI number | 3004478276 |
At a glance
- 10–99 Supplements
- Nov 21, 2019 Latest supplement decision
- Yes Withdrawn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: