PMA P130026S035
- Device
- TactiCath Quartz Contact Force Ablation Catheter
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S035
- Product code
- OAE
- Decision date
- 2018-07-31
- 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 for manufacturing modifications to the irrigation lumen subassembly process and includes updates to the polyimide tube cutting fixture and placement of polyimide tube over adhesive covered Inox irrigation tube.
Current openFDA PMA Record#
- Device
- TactiCath Quartz Contact Force Ablation Catheter
- Applicant
- St Jude Medical
- PMA number
- P130026
- Supplement
- S035
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2018-07-31
- Decision code
- APPR
- Date received
- 2018-07-05
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for manufacturing modifications to the irrigation lumen subassembly process and includes updates to the polyimide tube cutting fixture and placement of polyimide tube over adhesive covered Inox irrigation tube.