4/14/2023 0 Comments Dndc of pmma in dmf![]() Material and Performance CharacterizationĬlass II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement The Content and Format of an Abbreviated 510(k) Submissionħ. Please use the document number (668) to identify the guidance you are requesting. You may also send an e-mail request to to receive a copy of the guidance. Comments may not be acted upon by the Agency until the document is next revised or updated.įor questions regarding the use or interpretation of this guidance contact Hany Demian at 30 or by electronic mail at Additional CopiesĪdditional copies are available from the Internet. When submitting comments, please refer to the exact title of this guidance document. Department of Health and Human ServicesĬenter for Devices and Radiological Healthĭivision of General, Restorative, and Neurological DevicesĬomments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. This document supersedes "Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement 510(k)s Final Guidance for Industry" dated August 2, 2001.
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