PMA
P990037: VASCULAR SOLUTIONS DUETT SEALING DEVICE
FDA PMA · Device, hemostasis, vascular · Vascular Solutions, Inc.
Key facts
| PMA number | P990037 |
|---|---|
| Trade name | VASCULAR SOLUTIONS DUETT SEALING DEVICE |
| Generic name | Device, hemostasis, vascular |
| Applicant | Vascular Solutions, Inc. |
| Owner/operator | Vascular Solutions LLC |
| Product code | MGB |
| Approval date | Jun 22, 2000 |
| Docket number | 00M-1390 |
| Notice date | Jul 12, 2000 |
| Establishment registration | 2134812 |
| FEI number | 3002827704 |
At a glance
- 10–99 Supplements
- Nov 4, 2022 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- No Withdrawn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: