PMA P110016S088

Device: FlexAbility™ Ablation Catheter; FlexAbility™ Ablation Catheter, Sensor Enabled™
Applicant: ABBOTT MEDICAL
PMA number: P110016
Supplement: S088
Product code: OAD
Decision date: 2025-04-10
Classification: Cardiovascular
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: an expansion of sterilization capabilities, including validation of the maximum load configuration, an addition of preconditioning room, and parametric release for Cycle 219 at Centerpiece in Tijuana, Mexico

Current openFDA PMA Record#

Device: FlexAbility™ Ablation Catheter; FlexAbility™ Ablation Catheter, Sensor Enabled™
Applicant: ABBOTT MEDICAL
PMA number: P110016
Supplement: S088
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2025-04-10
Decision code: OK30
Date received: 2025-03-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an expansion of sterilization capabilities, including validation of the maximum load configuration, an addition of preconditioning room, and parametric release for Cycle 219 at Centerpiece in Tijuana, Mexico