PMA P030031S139

Device: Navistar Thermocool Catheter; Thermocool SmartTouch Catheter; Thermocool SmartTouch SF Catheter; Thermocool SF NAV Cathe
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S139
Product code: OAD
Decision date: 2025-02-25
Classification: Cardiovascular
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: an alternate supplier for molded piston components

Current openFDA PMA Record#

Device: Navistar Thermocool Catheter; Thermocool SmartTouch Catheter; Thermocool SmartTouch SF Catheter; Thermocool SF NAV Cathe
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S139
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2025-02-25
Decision code: OK30
Date received: 2025-02-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an alternate supplier for molded piston components