PMA
P040022: ANGIOLINK VASCULAR CLOSURE SYSTEM
FDA PMA · Device, hemostasis, vascular · Medtronic Vascular
Key facts
| PMA number | P040022 |
|---|---|
| Trade name | ANGIOLINK VASCULAR CLOSURE SYSTEM |
| Generic name | Device, hemostasis, vascular |
| Applicant | Medtronic Vascular |
| Owner/operator | Medtronic, Inc. |
| Product code | MGB |
| Approval date | Nov 3, 2004 |
| Docket number | 04M-0496 |
| Notice date | Nov 12, 2004 |
| Establishment registration | 1220452 |
| FEI number | 1220452 |
At a glance
- 1–9 Supplements
- May 24, 2007 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: