TactiFlex Ablation Catheter, Sensor Enabled, TactiSys Quartz Equipment, TactiSys Quartz, TactiFlex Radiofrequency C
FDA premarket approval P220013 · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
PMA numberP220013
Approval
- Applicant
- Abbott Medical
- Received
- August 15, 2022
- Decision date
- May 18, 2023 (APPR)
- Supplements
- 31, latest September 4, 2026
- Product code
- OAE – Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Approval order statement
Approval for the TactiFle Ablation Catheter, Sensor Enabled. This device is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation and concomitant atrial flutter, when used in conjunction with a compatible RF generator and three-dimensional mapping system.