PMA
P010016: ORCEL BILAYERED CELLULAR MATRIX
FDA PMA · Dressing, wound and burn, interactive · Forticell Bioscience
Key facts
| PMA number | P010016 |
|---|---|
| Trade name | ORCEL BILAYERED CELLULAR MATRIX |
| Generic name | Dressing, wound and burn, interactive |
| Applicant | Forticell Bioscience |
| Product code | MGR |
| Approval date | Aug 31, 2001 |
| Docket number | 01M-0413 |
| Notice date | Sep 20, 2001 |
At a glance
- 1–9 Supplements
- Jan 17, 2002 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- No Withdrawn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: