ATS Medical nets CE Mark, ISO for cardiac ablation products

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ATS Medical, a manufacturer of cardiac surgery products and services, has received ISO certification for its quality system to manufacture and CE Mark approval to distribute ATS CryoMaze cardiac ablation products in the European Union.

The approvals, in combination with the completion of transfer of the U.S. 510(k) rights and validation of the manufacturing processes, enable the company to sell the ATS-manufactured product line into the U.S. and Europe, according to the Minneapolis-based company.

The company said the regulatory approvals are the final step in the integration of the surgical ablation business, which it acquired in June 2007. Since the acquisition, ATS has purchased devices from the previous manufacturer to support worldwide sales.