American Medical Systems

American Medical Systems — FDA 510(k) Submissions

American Medical Systems has submitted 10 FDA 510(k) premarket notifications since 2008, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed, Powered Laser Surgical Instrument, Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling, Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed, Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator . Use the specialty filter in the sidebar to narrow results.