PMA P030031S078
- Device
- The ThermoCool SmartTouch SF Uni-Directional & Bi-Directional Navigational Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S078
- Product code
- OAD
- Decision date
- 2016-10-27
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Transfer of the extrusion process of the Reinforcing Sleeve subcomponent.
Current openFDA PMA Record#
- Device
- The ThermoCool SmartTouch SF Uni-Directional & Bi-Directional Navigational Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S078
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2016-10-27
- Decision code
- OK30
- Date received
- 2016-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of the extrusion process of the Reinforcing Sleeve subcomponent.