PMA
P000018: BETA-CATH (TM) SYSTEM
FDA PMA · Intravascular radiation delivery system · Best Vascular, Inc.
Key facts
| PMA number | P000018 |
|---|---|
| Trade name | BETA-CATH (TM) SYSTEM |
| Generic name | Intravascular radiation delivery system |
| Applicant | Best Vascular, Inc. |
| Owner/operator | Best Vascular, Inc. |
| Product code | MOU |
| Approval date | Nov 3, 2000 |
| Docket number | 00M-1649 |
| Notice date | Dec 13, 2000 |
| Establishment registration | 1062385 |
| FEI number | 3000205626 |
At a glance
- 10–99 Supplements
- Sep 26, 2024 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: