- Device
- TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S080
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2022-10-28
- Decision code
- OK30
- Date received
- 2022-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the Deflection Tester and a re-arrangement of the manufacturing workflow.