PMA
P800058: N.C.G.T. GRAFT
FDA PMA · Tissue graft of 6mm and greater · St. Jude Medical, Inc.
Key facts
| PMA number | P800058 |
|---|---|
| Trade name | N.C.G.T. GRAFT |
| Generic name | Tissue graft of 6mm and greater |
| Applicant | St. Jude Medical, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LXA |
| Approval date | Sep 8, 1981 |
| Docket number | 81M-0307 |
| Notice date | Oct 23, 1981 |
| Establishment registration | 3012179728 |
| FEI number | 1000526851 |
At a glance
- 10–99 Supplements
- Oct 25, 1994 Latest supplement decision
- Yes Withdrawn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: