PMA
P210017: Cross-Seal Suture-Mediated Vascular Closure Device System
FDA PMA · Device, hemostasis, vascular · Terumo Medical Corporation
Key facts
| PMA number | P210017 |
|---|---|
| Trade name | Cross-Seal Suture-Mediated Vascular Closure Device System |
| Generic name | Device, hemostasis, vascular |
| Applicant | Terumo Medical Corporation |
| Owner/operator | TERUMO MEDICAL CORP. |
| Product code | MGB |
| Approval date | Sep 26, 2023 |
| Establishment registration | 2243441 |
| FEI number | 2243441 |
At a glance
- None Supplements
- Sep 26, 2023 Latest supplement decision
- No Withdrawn
- Yes 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: