PMA P110016S065
- Device
- FlexAbility and FlexAbility SE Ablation Catheter and FlexAbility Cables, Sensor Enabled
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S065
- Product code
- OAD
- Decision date
- 2019-10-25
- 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 an additional sterilization chamber at Midwest Sterilization Corporation in Jackson, Missouri.
Current openFDA PMA Record#
- Device
- FlexAbility and FlexAbility SE Ablation Catheter and FlexAbility Cables, Sensor Enabled
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S065
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2019-10-25
- Decision code
- OK30
- Date received
- 2019-09-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an additional sterilization chamber at Midwest Sterilization Corporation in Jackson, Missouri.