- Device
- TactiCath Contact Force Ablation Catheter, Sensor Enabled
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S066
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2021-01-10
- Decision code
- APPR
- Date received
- 2020-10-28
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for modifications to the Instructions for Use (IFU) manuals to indicate the compatibility with the EnSite X EP System.