POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

FDA premarket approval P220032 · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

PMA numberP220032

Approval

Applicant
Boston Scientific Corporation
Received
December 20, 2022
Decision date
August 8, 2023 (APPR)
Supplements
12, latest May 29, 2026
Product code
OAE – Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

Official FDA PMA record

Approval order statement

Approval for the Boston Scientific Cardiac Cryoablation System using the POLARx Cryoablation Balloon Catheters. The device is indicated for the treatment of patients with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation (PAF). In addition it is intended for cryoablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation. The SMARTFREEZE Cryo-Console is intended to be used with POLARx cryoablation balloon catheters only.