PMA
P930038: Angio Seal Vascular Closure Device
FDA PMA · Device, hemostasis, vascular · Terumo Medical Corporation
Key facts
| PMA number | P930038 |
|---|---|
| Trade name | Angio Seal Vascular Closure Device |
| Generic name | Device, hemostasis, vascular |
| Applicant | Terumo Medical Corporation |
| Owner/operator | TERUMO MEDICAL CORP. |
| Product code | MGB |
| Approval date | Sep 30, 1996 |
| Docket number | 97M-0259 |
| Notice date | Jul 10, 1997 |
| Establishment registration | 2243441 |
| FEI number | 2243441 |
At a glance
- 100–999 Supplements
- Aug 4, 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- No Withdrawn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: