PMA P040036S089

Device: NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (ST)
Applicant: Biosense Webster, Inc.
PMA number: P040036
Supplement: S089
Product code: LPB
Decision date: 2022-09-09
Generic name: Cardiac ablation percutaneous catheter
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: NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (ST)
Applicant: Biosense Webster, Inc.
PMA number: P040036
Supplement: S089
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
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).