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Guidance for Industry and FDA Staff: Vocal Fold Medialization Devices - Premarket Notification [510(k)] Submissions
… a localized foreign body granulomatous reaction (i.e., “Teflon granuloma”) at the site of injection (Varvares,1995; Benjamin, 1987; Ellis, 1987). Teflon granulomas may lead to progressive dysphonia and … control animals (e.g., injection of product vehicle, Teflon as positive control) and should be of sufficient …