PMA P110016S094

Device: FlexAbility™ Ablation Catheter; FlexAbilityTM Ablation Catheter, Sensor EnabledTM
Applicant: ABBOTT MEDICAL
PMA number: P110016
Supplement: S094
Product code: OAD
Decision date: 2026-06-05
Classification: Cardiovascular
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: supplier process improvements and alternative sourcing for two catheter actuation components

Current openFDA PMA Record#

Device: FlexAbility™ Ablation Catheter; FlexAbilityTM Ablation Catheter, Sensor EnabledTM
Applicant: ABBOTT MEDICAL
PMA number: P110016
Supplement: S094
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2026-06-05
Decision code: OK30
Date received: 2026-05-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: supplier process improvements and alternative sourcing for two catheter actuation components