PMA
BP011600: Orcel
FDA PMA · Dressing, wound and burn, interactive · Ortec International, Inc.
Key facts
| PMA number | BP011600 |
|---|---|
| Trade name | Orcel |
| Generic name | Dressing, wound and burn, interactive |
| Applicant | Ortec International, Inc. |
| Owner/operator | ORTEC Co., LTD. |
| Product code | MGR |
| Approval date | Aug 31, 2001 |
| Establishment registration | 3009119999 |
| FEI number | 3009119999 |
At a glance
- None Supplements
- Aug 31, 2001 Latest supplement decision
- No Withdrawn
- No 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: