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

FDA premarket approval P220032 · decided 2023-08-08

Approval details

PMA number

P220032

Trade name

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

Generic name

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Applicant

Boston Scientific Corporation

Date received

2022-12-20

Decision date

2023-08-08

Days to decision

231 days

Decision code

APPR

Product code

OAE

Advisory committee

Cardiovascular

Expedited review

No

Location

St Paul, MN

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 SMARTFREE

510(k) clearances by this applicant