PMA
P800002: AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB
FDA PMA · Agent, absorbable hemostatic, collagen based · C.R. Bard, Inc.
Key facts
| PMA number | P800002 |
|---|---|
| Trade name | AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB |
| Generic name | Agent, absorbable hemostatic, collagen based |
| Applicant | C.R. Bard, Inc. |
| Owner/operator | C. R. Bard, Inc. |
| Product code | LMF |
| Approval date | Oct 24, 1980 |
| Docket number | 83M-0026 |
| Notice date | Feb 15, 1983 |
| Establishment registration | 1223089 |
| FEI number | 1000120505 |
At a glance
- 10–99 Supplements
- Sep 29, 2026 Latest supplement decision
- No Withdrawn
- No 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: