PMA P030031S106
- Device
- Thermocool Smarttouch SF
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S106
- Product code
- OAD
- Decision date
- 2020-06-26
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Implementation of an automated resistance inspection process.
Current openFDA PMA Record#
- Device
- Thermocool Smarttouch SF
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S106
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2020-06-26
- Decision code
- OK30
- Date received
- 2020-06-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an automated resistance inspection process.