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Ceram Helps Greatbatch Medical Gain FDA Clearance

Ceram, an independent materials technology company, recently partnered with Greatbatch Medical, providers of critical technologies used in medical devices, to help Greatbatch gain FDA clearance of its hydroxyapatite coating master file by providing all the necessary testing on the coating for a 510(k) implant submission.

In an effort to supply its French-produced coated devices marketed by its customers into the U.S. market, Greatbatch Medical submitted a detailed hydroxyapatite coating master file to FDA in conjunction with the customer-submitted 510(k) submission. Ceram developed a comprehensive testing program to supply complete data and analysis to support the submission.

Working with implant manufacturers and bone replacement material suppliers, Ceram offers both a pre- and post-regulatory approval service to the medical device industry. (Source: Ceram)