PMA P110016S036
- Device
- FlexAbility Ablation Catheter (Bi-Directional)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S036
- Product code
- OAD
- Decision date
- 2016-10-07
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Approval to add a manufacturing step to the handle assembly process to the Flexability bi-directional catheter.
Current openFDA PMA Record#
- Device
- FlexAbility Ablation Catheter (Bi-Directional)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S036
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2016-10-07
- Decision code
- APPR
- Date received
- 2016-09-08
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to add a manufacturing step to the handle assembly process to the Flexability bi-directional catheter.