PMA
P950005: WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER
FDA PMA · Cardiac ablation percutaneous catheter · Biosense Webster, Inc.
Key facts
| PMA number | P950005 |
|---|---|
| Trade name | WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | Biosense Webster, Inc. |
| Owner/operator | BIOSENSE WEBSTER, INC. |
| Product code | LPB |
| Approval date | Sep 30, 1997 |
| Docket number | 98M-0678 |
| Notice date | Sep 8, 1998 |
| Establishment registration | 3013300026 |
| FEI number | 3013300026 |
At a glance
- 10–99 Supplements
- Feb 26, 2025 Latest supplement decision
- No Withdrawn
- No 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: