PMA
P040036: NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER
FDA PMA · Cardiac ablation percutaneous catheter · Biosense Webster, Inc.
Key facts
| PMA number | P040036 |
|---|---|
| Trade name | NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | Biosense Webster, Inc. |
| Owner/operator | BIOSENSE WEBSTER, INC. |
| Product code | LPB |
| Approval date | Aug 11, 2006 |
| Docket number | 06M-0374 |
| Notice date | Sep 12, 2006 |
| Establishment registration | 3013300026 |
| FEI number | 3013300026 |
At a glance
- 10–99 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- No Withdrawn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: