PMA P130026S052
- Device
- TactiCath Quartz Contact Force Ablation Catheter and TactiCath Contact Force Ablation Catheter, Sensor Enabled
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S052
- Product code
- OAE
- Decision date
- 2019-10-25
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Add an additional sterilization chamber at Midwest Sterilization Corporation in Jackson, Missouri.
Current openFDA PMA Record#
- Device
- TactiCath Quartz Contact Force Ablation Catheter and TactiCath Contact Force Ablation Catheter, Sensor Enabled
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S052
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2019-10-25
- Decision code
- OK30
- Date received
- 2019-09-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an additional sterilization chamber at Midwest Sterilization Corporation in Jackson, Missouri.