PMA
P030031: BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS
FDA PMA · Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter · Biosense Webster, Inc.
Key facts
| PMA number | P030031 |
|---|---|
| Trade name | BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
| Applicant | Biosense Webster, Inc. |
| Owner/operator | BIOSENSE WEBSTER, INC. |
| Product code | OAD |
| Approval date | Nov 5, 2004 |
| Docket number | 04M-0497 |
| Notice date | Nov 12, 2004 |
| Establishment registration | 3013300026 |
| FEI number | 3013300026 |
At a glance
- 100–999 Supplements
- Sep 15, 2026 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- No Withdrawn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: