- Device
- TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S070
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2021-11-04
- Decision code
- APPR
- Date received
- 2021-04-01
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the TactiCath Contact Force Ablation Catheter, Sensor Enabled. The device is indicated for use in cardiac electrophysiology mapping and for the treatment of drug refractory recurrent symptomatic, paroxysmal, and persistent atrial fibrillation, when used in conjunction with a compatible RF generator and three-dimensional mapping system.