PMA
P990025: NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
FDA PMA · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING · Biosense Webster, Inc.
Key facts
| PMA number | P990025 |
|---|---|
| Trade name | NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER |
| Generic name | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
| Applicant | Biosense Webster, Inc. |
| Owner/operator | BIOSENSE WEBSTER, INC. |
| Product code | DRF |
| Approval date | Jun 15, 2000 |
| Docket number | 00M-1388 |
| Notice date | Jul 11, 2000 |
| Establishment registration | 9673241 |
| FEI number | 3003248396 |
At a glance
- 10–99 Supplements
- Feb 25, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: