PMA supplement
P810040 S005: SUPERSTAT
FDA PMA supplement · Superstat Corp.
Key facts
| Original PMA | P810040 |
|---|---|
| Supplement number | S005 |
| Trade name | SUPERSTAT |
| Generic name | Agent, absorbable hemostatic, collagen based |
| Applicant | Superstat Corp. |
| Product code | LMF |
| Received date | Dec 14, 1983 |
| Decision date | Feb 22, 1984 |
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: