PMA P130026S055
- Device
- TactiCath Contact Force Ablation Catheter, Sensor Enabled
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S055
- Product code
- OAE
- Decision date
- 2020-01-14
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Additional subcomponent supplier for the titanium deformable body.
Current openFDA PMA Record#
- Device
- TactiCath Contact Force Ablation Catheter, Sensor Enabled
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S055
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2020-01-14
- Decision code
- OK30
- Date received
- 2019-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional subcomponent supplier for the titanium deformable body.