www.fdanews.com/articles/87799-uroplasty-s-next-generation-device-to-treat-overactive-bladder-awarded-ce-marking
UROPLASTY'S NEXT-GENERATION DEVICE TO TREAT OVERACTIVE BLADDER AWARDED CE MARKING
June 22, 2006
Uroplasty, Inc. announced their second major approval for the Company's next-generation Urgent PC Neuromodulation System. AMTAC Certification Services, Uroplasty's Notified Body, granted European CE marking and approved the Company's request to sell this new model of the Urgent PC in Europe for the treatment of overactive bladder symptoms and for the treatment of fecal incontinence. Regulatory clearance from the U.S. FDA is currently pending.
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