- Device
- TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ (A-TFDM-D, A-TFDM-F, A-TFDM-J, A-TFDM-DD, A-TFDM-DF, A-TFDM-FF, A-TFDM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P220013
- Supplement
- S028
- Decision date
- 2026-09-04
- Decision code
- APPR
- Date received
- 2026-03-02
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- The TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ is indicated for use in The TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ is indicated for use in cardiac electrophysiological mapping and ablation for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation and concomitant atrial flutter, when used in conjunction with a compatible radiofrequency (RF) or pulsed field (PF) generator and three-dimensional mapping system.