PMA P130026S040
- Device
- TactiCath Quartz Contract Force Ablation Catheter
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S040
- Product code
- OAE
- Decision date
- 2019-03-14
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Addition of a manufacturing aide for the distal tip adhesive application process of the TactiCath Quartz Contact Force Ablation Catheter.
Current openFDA PMA Record#
- Device
- TactiCath Quartz Contract Force Ablation Catheter
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S040
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2019-03-14
- Decision code
- OK30
- Date received
- 2019-02-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a manufacturing aide for the distal tip adhesive application process of the TactiCath Quartz Contact Force Ablation Catheter.