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Establishment Registration & Device Listing

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Product Code : OAE

Establishment
Name

Registration Number

Current
Registration Yr

STOCKERT GMBH

GERMANY

9612355

2013

catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Stockert-70

Manufacturer

Sterigenics EO Canada, Inc.

CANADA

9611665

2013

catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - accessory Manual retraction kit; Arctic Front Advance cardiac cryoablation catheter; Arctic Front cardiac cryoablation catheter; Freezor MAX cardiac cryoablation catheter

Contract Sterilizer

Medtronic CryoCath LP

CANADA

3002648230

2013

catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Arctic Front Advance cardiac cryoablation catheter; Arctic Front cardiac cryoablation catheter; Freezor MAX cardiac cryoablation catheter

Manufacturer

HEI INC., ADVANCED MEDICAL DIVISION

CO/USA

1721752

2013

catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - CoolFlow

Contract Manufacturer

CARDIOFOCUS, INC.

MA/USA

1225698

2013

catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - HeartLight (EAS-AC) Cardiac Ablation System

U.S. Manufacturer of Export Only Devices

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