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Are DSM PTG Polyurethanes suitable for human implantation?

April 26, 2017DSM Human implantation polyurethanes ptg suitable

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Are DSM PTG Polyurethanes suitable for human implantation?

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FDA and foreign regulatory authorities have approved a variety of chronically implanted devices using BioSpan® and Bionate polyurethanes. DSM PTG’s BioSpan® segmented polyurethane and Bionate® polycarbonate-urethane are two of the most extensively tested biomaterials available today, and each is backed by a comprehensive FDA Masterfile. Ultimately, only the FDA and foreign regulatory bodies can determine if a device is suitable for human implantation.