Uroplasty receives approvable letter from FDA for incontinence implant

By Lisa Kerner

Charlotte, N.C., Sept. 13 - Uroplasty, Inc. said it received an approvable letter from the Food and Drug Administration in response to its pre-market approval application for Macroplastique Implants for the treatment of female stress urinary incontinence.

Approval of the implants is subject to completion of the FDA's audit of Uroplasty's manufacturing facilities in Minnesota and the Netherlands.

Macroplastique, a soft tissue, injectable bulking agent, is already used outside of the United States for stress urinary incontinence resulting primarily from intrinsic sphincter deficiency.

Uroplasty is a medical device company based in Minnetonka, Minn.

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