PMA P030031S097
- Device
- ThermaCool SmartTouch SF Bi-directional and ThermoCool SmartTouch SF Uni-directional navigation Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S097
- Product code
- OAD
- Decision date
- 2019-04-19
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Add a semi-automated prep shaft machine as an alternate manufacturing process for the ThermoCool SmartTouch and ThermoCool SmartTouch SF catheters.
Current openFDA PMA Record#
- Device
- ThermaCool SmartTouch SF Bi-directional and ThermoCool SmartTouch SF Uni-directional navigation Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S097
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2019-04-19
- Decision code
- OK30
- Date received
- 2019-04-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a semi-automated prep shaft machine as an alternate manufacturing process for the ThermoCool SmartTouch and ThermoCool SmartTouch SF catheters.