PMA supplement
BP953200 S078: Apligraf
FDA PMA supplement · 135 Day Track for 30 Day Notification · Organogenesis, Inc.
Key facts
| Original PMA | BP953200 |
|---|---|
| Supplement number | S078 |
| Supplement type | 135 Day Track for 30 Day Notification |
| Trade name | Apligraf |
| Generic name | Pfc |
| Applicant | Organogenesis, Inc. |
| Product code | PFC |
| Received date | Aug 11, 2014 |
| Decision date | Dec 22, 2014 |
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: