PMA
N17600: AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT)
FDA PMA · Agent, absorbable hemostatic, collagen based · Davol Inc., Sub. C. R. Bard, Inc.
Key facts
| PMA number | N17600 |
|---|---|
| Trade name | AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT) |
| Generic name | Agent, absorbable hemostatic, collagen based |
| Applicant | Davol Inc., Sub. C. R. Bard, Inc. |
| Owner/operator | C. R. Bard, Inc. |
| Product code | LMF |
| Approval date | Aug 26, 1976 |
| Establishment registration | 1213643 |
| FEI number | 1213643 |
At a glance
- 10–99 Supplements
- Jul 15, 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- No Withdrawn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: