PMA
P810040: SUPERSTAT
FDA PMA · Agent, absorbable hemostatic, collagen based · Superstat Corp.
Key facts
| PMA number | P810040 |
|---|---|
| Trade name | SUPERSTAT |
| Generic name | Agent, absorbable hemostatic, collagen based |
| Applicant | Superstat Corp. |
| Product code | LMF |
| Approval date | Jan 29, 1982 |
| Docket number | 82M-0023 |
| Notice date | Jun 25, 1982 |
| FEI number | 3001452136 |
At a glance
- 1–9 Supplements
- Apr 21, 1995 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None 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: