PMA P110016S064
- Device
- FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S064
- Product code
- OAD
- Decision date
- 2019-10-09
- 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 for the addition of a warning statement to the instructions for use regarding atrioesophageal fistulas.
Current openFDA PMA Record#
- Device
- FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S064
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2019-10-09
- Decision code
- APPR
- Date received
- 2019-09-12
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of a warning statement to the instructions for use regarding atrioesophageal fistulas.