- Device
- TactiCath™ CF Ablation Catheter, Sensor Enabled™ (A-TCSE-D; A-TCSE-F; A-TCSE-J; A-TCSE-DD; A-TCSE-DF; A-TCSE-FF; A-TCSE-
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S099
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2026-05-15
- Decision code
- OK30
- Date received
- 2026-04-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- new equipment for the implementation of an automated inspection process for catheter assembly and electrical testing