PMA P220013S022

Device: TactiFlex™ Sensor Enabled™ Ablation Catheter
Applicant: ABBOTT MEDICAL
PMA number: P220013
Supplement: S022
Product code: OAE
Decision date: 2026-05-28
Classification: Cardiovascular
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement: Approval for labeling changes that would allow for alternative imaging modalities, such as intracardiac echocardiography (ICE), to aid in the navigation and positioning of the TactiFlex, Sensor Enabled (SE) Ablation Catheter.

Current openFDA PMA Record#

Device: TactiFlex™ Sensor Enabled™ Ablation Catheter
Applicant: ABBOTT MEDICAL
PMA number: P220013
Supplement: S022
Product code: OAE
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date: 2026-05-28
Decision code: APPR
Date received: 2025-09-17
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for labeling changes that would allow for alternative imaging modalities, such as intracardiac echocardiography (ICE), to aid in the navigation and positioning of the TactiFlex, Sensor Enabled (SE) Ablation Catheter.