PMA P030031S128

Device: Celsius RMT ThermoCool Cather, Celsius ThermoCool Cather, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool NAV Catheter
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S128
Product code: OAD
Decision date: 2022-09-30
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
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: Celsius RMT ThermoCool Cather, Celsius ThermoCool Cather, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool NAV Catheter
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S128
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
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.