PMA
P010068: NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER
FDA PMA · Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter · Biosense Webster, Inc.
Key facts
| PMA number | P010068 |
|---|---|
| Trade name | NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER |
| 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 | Sep 27, 2002 |
| Docket number | 03M-0049 |
| Notice date | Feb 10, 2003 |
| Establishment registration | 3013300026 |
| FEI number | 3013300026 |
At a glance
- 10–99 Supplements
- Feb 26, 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- No Withdrawn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: