PMA
P930030: HEMOSTAGENE(R) ABSORBABLE COLL. HEMOSTATIC SPONGE
FDA PMA · Agent, absorbable hemostatic, collagen based · Coletica S.A.
Key facts
| PMA number | P930030 |
|---|---|
| Trade name | HEMOSTAGENE(R) ABSORBABLE COLL. HEMOSTATIC SPONGE |
| Generic name | Agent, absorbable hemostatic, collagen based |
| Applicant | Coletica S.A. |
| Product code | LMF |
| Approval date | Aug 15, 1995 |
| Docket number | 95m-0393 |
| Notice date | Dec 19, 1995 |
At a glance
- 1–9 Supplements
- Nov 30, 1995 Latest supplement decision
- Yes Withdrawn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: