PMA P030031S122

Device: CELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH, THERMOCOOL SMARTTOU
Applicant: Biosense Webster, Inc.
Product code: OAD
Decision date: 2022-03-08
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: Approval for the nGEN Generator (compatible with the THERMOCOOL, NAVISTAR and CELSIUS catheters), the addition of a manufacturing site in Israel to manufacture the nGEN Generator and nGEN Pump, and the addition of a manufacturing site in Mexico to manufacture the Interface Cable between the CELSIUS catheters to the nGEN Generator.

Current openFDA PMA Record#

Device: CELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH, THERMOCOOL SMARTTOU
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S122
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2022-03-08
Decision code: APPR
Date received: 2021-06-30
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the nGEN Generator (compatible with the THERMOCOOL, NAVISTAR and CELSIUS catheters), the addition of a manufacturing site in Israel to manufacture the nGEN Generator and nGEN Pump, and the addition of a manufacturing site in Mexico to manufacture the Interface Cable between the CELSIUS catheters to the nGEN Generator.