PMA
P780002: DARDIK BIOGRAFT
FDA PMA · Tissue graft of 6mm and greater · Synovis Surgical Innovations
Key facts
| PMA number | P780002 |
|---|---|
| Trade name | DARDIK BIOGRAFT |
| Generic name | Tissue graft of 6mm and greater |
| Applicant | Synovis Surgical Innovations |
| Owner/operator | BAXTER HEALTHCARE CORPORATION |
| Product code | LXA |
| Approval date | Jan 17, 1979 |
| Notice date | Jul 24, 1979 |
| Establishment registration | 2183620 |
| FEI number | 2183620 |
At a glance
- 1–9 Supplements
- Nov 24, 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- Yes Withdrawn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: