PMA P220013S019
- Device
- TactiFlex Ablation Catheter, Sensor Enabled
- Applicant
- ABBOTT MEDICAL
- PMA number
- P220013
- Supplement
- S019
- Product code
- OAE
- Decision date
- 2025-06-20
- Classification
- Cardiovascular
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- modifications to the device packaging involving the distal tip securement method
Current openFDA PMA Record#
- Device
- TactiFlex Ablation Catheter, Sensor Enabled
- Applicant
- ABBOTT MEDICAL
- PMA number
- P220013
- Supplement
- S019
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2025-06-20
- Decision code
- APPR
- Date received
- 2025-03-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- modifications to the device packaging involving the distal tip securement method