PMA P030031S144

Device: THERMOCOOL SMARTTOUCH SF (Uni-Directional and Bi-Directional)/DUAL ENERGYTHERMOCOOL SMARTTOUCH SF CATHETERS
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S144
Product code: OAD
Decision date: 2026-06-10
Classification: Cardiovascular
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: an additional supplier for critical components

Current openFDA PMA Record#

Device: THERMOCOOL SMARTTOUCH SF (Uni-Directional and Bi-Directional)/DUAL ENERGYTHERMOCOOL SMARTTOUCH SF CATHETERS
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S144
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2026-06-10
Decision code: OK30
Date received: 2026-06-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an additional supplier for critical components