PMA
P050007: STARCLOSE VASCULAR CLOSURE SYSTEM
FDA PMA · Device, hemostasis, vascular · Abbott Vascular Devices
Key facts
| PMA number | P050007 |
|---|---|
| Trade name | STARCLOSE VASCULAR CLOSURE SYSTEM |
| Generic name | Device, hemostasis, vascular |
| Applicant | Abbott Vascular Devices |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MGB |
| Approval date | Dec 21, 2005 |
| Docket number | 06M-0016 |
| Notice date | Jan 13, 2006 |
| Establishment registration | 2939561 |
| FEI number | 3004635528 |
At a glance
- 10–99 Supplements
- Apr 17, 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- No Withdrawn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: