PMA
P950032: APLIGRAF (GRAFTSKIN)
FDA PMA · Dressing, wound and burn, interactive · Organogenesis, Inc.
Key facts
| PMA number | P950032 |
|---|---|
| Trade name | APLIGRAF (GRAFTSKIN) |
| Generic name | Dressing, wound and burn, interactive |
| Applicant | Organogenesis, Inc. |
| Owner/operator | Organogenesis Inc. |
| Product code | MGR |
| Approval date | May 22, 1998 |
| Docket number | 98M-0992 |
| Notice date | Dec 17, 1998 |
| Establishment registration | 1221816 |
| FEI number | 1000148471 |
At a glance
- 10–99 Supplements
- Mar 10, 2014 Latest supplement decision
- No Withdrawn
- Yes 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: