PMA P040036S090

Device: ThermoCool SmartTouch Catheters, NaviStar ThermoCool Catheter, NaviStar RMT ThermoCool Catheter, EZ Steer ThermoCool NAV
Applicant: Biosense Webster, Inc.
PMA number: P040036
Supplement: S090
Product code: LPB
Decision date: 2022-09-30
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: Add an additional chamber for the sterilization of catheters and cables at the Isomedix Operation, Inc. (Steris Grand Prairie) facility in Grand Prairie, Texas.

Current openFDA PMA Record#

Device: ThermoCool SmartTouch Catheters, NaviStar ThermoCool Catheter, NaviStar RMT ThermoCool Catheter, EZ Steer ThermoCool NAV
Applicant: Biosense Webster, Inc.
PMA number: P040036
Supplement: S090
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2022-09-30
Decision code: OK30
Date received: 2022-09-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add an additional chamber for the sterilization of catheters and cables at the Isomedix Operation, Inc. (Steris Grand Prairie) facility in Grand Prairie, Texas.