- Device
- Navistar Thermocool, EZ Steer Thermocool Nav Bi- Directional, Navistar RMT Thermocool, Thermocool SF Nav Bi-directional,
- Applicant
- Biosense Webster, Inc.
- PMA number
- P040036
- Supplement
- S079
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2021-04-07
- Decision code
- APPR
- Date received
- 2021-03-02
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of warnings from other catheter lines and the clarification of existing warnings and instructions.