PMA
P960007: TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
FDA PMA · Dressing, wound and burn, interactive · Shire Regenerative Medicine
Key facts
| PMA number | P960007 |
|---|---|
| Trade name | TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE |
| Generic name | Dressing, wound and burn, interactive |
| Applicant | Shire Regenerative Medicine |
| Product code | MGR |
| Approval date | Mar 18, 1997 |
| Docket number | 98M-0993 |
| Notice date | Dec 7, 1998 |
At a glance
- 10–99 Supplements
- Sep 20, 2011 Latest supplement decision
- No Withdrawn
- No 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: