PMA P220013S023

Device: TactiFlex™ Ablation Catheter, Sensor Enabled ™ (TactiFlex SE)
Applicant: ABBOTT MEDICAL
PMA number: P220013
Supplement: S023
Product code: OAE
Decision date: 2025-10-30
Classification: Cardiovascular
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement: an alternative manufacturing process for the TactiFlex SE Tip Thermocouple (TCT) configuration

Current openFDA PMA Record#

Device: TactiFlex™ Ablation Catheter, Sensor Enabled ™ (TactiFlex SE)
Applicant: ABBOTT MEDICAL
PMA number: P220013
Supplement: S023
Product code: OAE
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date: 2025-10-30
Decision code: OK30
Date received: 2025-09-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an alternative manufacturing process for the TactiFlex SE Tip Thermocouple (TCT) configuration