PMA supplement
P060038 S012: MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)
FDA PMA supplement · Normal 180 Day Track No User Fee · Corcym Canada Corp
Key facts
| Original PMA | P060038 |
|---|---|
| Supplement number | S012 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV) |
| Generic name | Heart-valve, non-allograft tissue |
| Applicant | Corcym Canada Corp |
| Product code | LWR |
| Received date | Apr 12, 2012 |
| Decision date | Oct 9, 2012 |
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: