PMA
P890045: GELSEAL TM TRIAXIAL VASCULAR GRAFT
FDA PMA · GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE · Carbomedics, Inc.
Key facts
| PMA number | P890045 |
|---|---|
| Trade name | GELSEAL TM TRIAXIAL VASCULAR GRAFT |
| Generic name | GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE |
| Applicant | Carbomedics, Inc. |
| Product code | MAL |
| Approval date | Jan 11, 1993 |
| Docket number | 93M-0023 |
| Notice date | May 3, 1993 |
| FEI number | 1627803 |
At a glance
- 1–9 Supplements
- Jul 5, 1995 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 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: