Navistar Thermocool Deflectable Diagnostic/Ablation Catheter
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER FDA PMA
- Generic Name
- Cardiac ablation percutaneous catheter FDA PMA
Identifiers
- PMA Number
- P040036 FDA PMA
- FDA Product Code
- LPB FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Navistar Thermocool Deflectable Diagnostic/Ablation Catheter is a cardiac ablation percutaneous catheter used for catheter-based cardiac electrophysiological mapping, stimulation, and recording. It provides location information when used with the CARTO EP/XP Navigation System and is indicated for the treatment of recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (MI) in adults.
This catheter is supplied as part of the Navistar Thermocool system and is used with the Stockert 70 Radiofrequency (RF) Generator. The device is authorized under FDA PMA approval and includes multiple models (N175TBH, N175TCH, N175TDH, N175TFH, N175TCBH, N175TCCH, N175TCDH, N175TCFH, and N175TCJH). The catheter is manufactured by Biosense Webster Inc. in Irvine, California.
Frequently asked questions
What is the primary purpose of the Thermocool Smarttouch Bi-directional Navigation Catheter?
This catheter is used for catheter-based cardiac electrophysiological mapping, stimulation, and recording. It provides location information when used with the CARTO EP/XP Navigation System and is indicated for treating recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior myocardial infarction in adults.
How is the Thermocool Smarttouch Catheter supplied?
The catheter is supplied as part of the Navistar Thermocool system and is used with the Stockert 70 Radiofrequency Generator. It is manufactured by Biosense Webster Inc. in Irvine, California.
What models of the Thermocool Smarttouch Catheter are available?
Multiple models are available including N175TBH, N175TCH, N175TDH, N175TFH, N175TCBH, N175TCCH, N175TCDH, N175TCFH, and N175TCJH.
Is the Thermocool Smarttouch Catheter single-use or reusable?
The device data does not specify whether the catheter is single-use or reusable. This information would typically be found in the device's instructions for use or product labeling.
What is the regulatory status of the Thermocool Smarttouch Catheter?
The device is authorized under FDA PMA approval. The FDA PMA approval was granted on August 11, 2006, for the treatment of recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior myocardial infarction in adults.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P040036 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biosense Webster Inc
- FDA Applicant
- Biosense Webster, Inc.
Sources (1)
- FDA PMA P040036 24 fields · synced Sep 18, 2026