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701 Pennsylvania Avenue, Ste. 800 Washington, DC 200042654 Tel: 202 783 8700 Fax: 202 783 8750 www.AdvaMed.orgJanuary 19, 2016 Division of Dockets Management (HFA305) Food and Drug Administration 5630

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Content and submission draft refers to the information and documents that need to be submitted for review and approval before final submission.

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