PMA P030031S127

Device: CELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH (ST), THERMOCOOL SMAR
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S127
Product code: OAD
Decision date: 2022-09-09
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: Approval for software and hardware modifications for the nGEN Generator (compatible with the THERMOCOOL, NAVISTAR, and CELSIUS catheters).

Current openFDA PMA Record#

Device: CELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH (ST), THERMOCOOL SMAR
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S127
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2022-09-09
Decision code: APPR
Date received: 2022-06-10
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for software and hardware modifications for the nGEN Generator (compatible with the THERMOCOOL, NAVISTAR, and CELSIUS catheters).