PMA P030031S113
- Device
- Thermocool Smarttouch SF
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S113
- Product code
- OAD
- Decision date
- 2021-03-02
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Add an additional supplier for the Pebax 40D Tubing Fluid Lumen component.
Current openFDA PMA Record#
- Device
- Thermocool Smarttouch SF
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S113
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-03-02
- Decision code
- OK30
- Date received
- 2021-02-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an additional supplier for the Pebax 40D Tubing Fluid Lumen component.