PMA P130026S072
- Device
- TactiCath Contact Force Ablation Catheter, Sensor Enabled
- Applicant
- St Jude Medical
- Product code
- OAE
- Decision date
- 2022-03-04
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Approval for a change to a patient-contacting adhesive material and the curing mechanism.
Current openFDA PMA Record#
- Device
- TactiCath Contact Force Ablation Catheter, Sensor Enabled
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S072
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2022-03-04
- Decision code
- APPR
- Date received
- 2021-04-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to a patient-contacting adhesive material and the curing mechanism.