PMA P030031S114

Device: Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S114
Product code: OAD
Decision date: 2021-04-07
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: Approval for the addition of warnings from other catheter lines and the clarification of existing warnings and instructions.

Current openFDA PMA Record#

Device: Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S114
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
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.