PMA P110016S089

Device: FlexAbility™ Ablation Catheter, Sensor Enabled™
Applicant: ABBOTT MEDICAL
PMA number: P110016
Supplement: S089
Product code: OAD
Decision date: 2025-10-16
Classification: Cardiovascular
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: approval of a revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P110016/S080.

Current openFDA PMA Record#

Device: FlexAbility™ Ablation Catheter, Sensor Enabled™
Applicant: ABBOTT MEDICAL
PMA number: P110016
Supplement: S089
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2025-10-16
Decision code: APPR
Date received: 2025-04-07
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of a revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P110016/S080.