PMA supplement
P960007 S019: TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
FDA PMA supplement · 30-Day Notice · Shire Regenerative Medicine
Key facts
| Original PMA | P960007 |
|---|---|
| Supplement number | S019 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE |
| Generic name | Dressing, wound and burn, interactive |
| Applicant | Shire Regenerative Medicine |
| Product code | MGR |
| Received date | Jul 26, 2010 |
| Decision date | Aug 25, 2010 |
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: