PMA P220013

Device: TactiFlex™ Ablation Catheter, Sensor Enabled™
Applicant: ABBOTT MEDICAL
Product code: OAE
Decision date: 2026-09-22
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement: approval for a predetermined change control plan (PCCP) TactiFlex Ablation Catheter, Sensor Enabled Predetermined Change Control Plan Version A that encompasses the change to the manufacturing location of the deflectable subassembly for subject catheter.

Current openFDA PMA Record#

Device: TactiFlex™ Ablation Catheter, Sensor Enabled™
Applicant: ABBOTT MEDICAL
PMA number: P220013
Supplement: S034
Product code: OAE
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date: 2026-09-22
Decision code: APPR
Date received: 2026-08-10
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a predetermined change control plan (PCCP) TactiFlex Ablation Catheter, Sensor Enabled Predetermined Change Control Plan Version A that encompasses the change to the manufacturing location of the deflectable subassembly for subject catheter.