PMA supplement
P950032 S016: APLIGRAF (GRAFTSKIN)
FDA PMA supplement · Normal 180 Day Track · Organogenesis, Inc.
Key facts
| Original PMA | P950032 |
|---|---|
| Supplement number | S016 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | APLIGRAF (GRAFTSKIN) |
| Generic name | Dressing, wound and burn, interactive |
| Applicant | Organogenesis, Inc. |
| Product code | MGR |
| Received date | Dec 23, 1999 |
| Decision date | Jun 20, 2000 |
| Docket number | 00M-1508 |
| Notice date | Sep 11, 2000 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: