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WASHINGTON (AP) -- A California company has received government approval to market an over-the-counter device to help men with sexual dysfunction.
The Food and Drug Administration said Friday that they had approved ACTIS, which was described by its maker, VIVUS of Mountain View, Calif., as "an adjustable constriction band used to enhance the erection process in men with erectile dysfunction."
ACTIS was approved as a prescription device in 1996 and was first marketed in 1997.
"Given its safety record, we expect that the product will be well received by consumers," Terry Nida, VIVUS vice president of marketing, said in a statement. "Our plan calls for selling ACTIS through major pharmacy channels and through e-commerce efforts."
