PMA
P100013: CORDIS EXOSEAL VASCULAR CLOSURE DEVICE
FDA PMA · Device, hemostasis, vascular · Cordis US Corporation
Key facts
| PMA number | P100013 |
|---|---|
| Trade name | CORDIS EXOSEAL VASCULAR CLOSURE DEVICE |
| Generic name | Device, hemostasis, vascular |
| Applicant | Cordis US Corporation |
| Owner/operator | Cordis US Corp. |
| Product code | MGB |
| Approval date | May 19, 2011 |
| Docket number | 11M-0430 |
| Notice date | Jun 3, 2011 |
| Establishment registration | 1016427 |
| FEI number | 1016427 |
At a glance
- 10–99 Supplements
- Jun 23, 2026 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- No Withdrawn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: