PMA P130026S038
- Device
- TactiCath Contact Force Ablation Catheter, Sensor Enabled
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S038
- Product code
- OAE
- Decision date
- 2019-02-11
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Approval to add additional manufacturing site and additional sterilization site in Costa Rica for the TactiCath SE.
Current openFDA PMA Record#
- Device
- TactiCath Contact Force Ablation Catheter, Sensor Enabled
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S038
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2019-02-11
- Decision code
- APPR
- Date received
- 2019-01-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to add additional manufacturing site and additional sterilization site in Costa Rica for the TactiCath SE.