PMA supplement
P000018 S008: NOVOSTE BETA-CATH SYSTEM
FDA PMA supplement · Real-Time Process · Best Vascular, Inc.
Key facts
| Original PMA | P000018 |
|---|---|
| Supplement number | S008 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | NOVOSTE BETA-CATH SYSTEM |
| Generic name | Intravascular radiation delivery system |
| Applicant | Best Vascular, Inc. |
| Product code | MOU |
| Received date | Feb 2, 2001 |
| Decision date | Oct 26, 2001 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: