PMA
P150022: CLOSER VASCULAR SEALING SYSTEM
FDA PMA · Device, hemostasis, vascular · Rex Medical, L.P.
Key facts
| PMA number | P150022 |
|---|---|
| Trade name | CLOSER VASCULAR SEALING SYSTEM |
| Generic name | Device, hemostasis, vascular |
| Applicant | Rex Medical, L.P. |
| Owner/operator | REX MEDICAL LP |
| Product code | MGB |
| Approval date | Feb 12, 2016 |
| Docket number | 16M-0805 |
| Notice date | Mar 3, 2016 |
| Establishment registration | 3003862657 |
| FEI number | 3003862657 |
At a glance
- 1–9 Supplements
- Oct 1, 2018 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- No Withdrawn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: