PMA
P150006: CELT ACD VASCULAR CLOSURE DEVICE
FDA PMA · Device, hemostasis, vascular · Vasorum, Ltd.
Key facts
| PMA number | P150006 |
|---|---|
| Trade name | CELT ACD VASCULAR CLOSURE DEVICE |
| Generic name | Device, hemostasis, vascular |
| Applicant | Vasorum, Ltd. |
| Owner/operator | Vasorum Ltd |
| Product code | MGB |
| Approval date | Jul 20, 2016 |
| Docket number | 16m-2185 |
| Notice date | Jul 25, 2016 |
| Establishment registration | 3009984513 |
| FEI number | 3009984513 |
At a glance
- 1–9 Supplements
- Dec 18, 2025 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- No Withdrawn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: