Tension-free sling receives premarket clearance from the FDA
September 1, 2005
Uroplasty, Inc. has received FDA 510(k) premarket clearance to distribute I-STOP, a polypropylene, tension-free mid-urethral sling for the treatment of female urinary stress incontinence.
Uroplasty, Inc. has received FDA 510(k) premarket clearance to distribute I-STOP, a polypropylene, tension-free mid-urethral sling for the treatment of female urinary stress incontinence.
Through an exclusive manufacturing and distribution arrangement with CL Medical of Lyon, France, Uroplasty said it will introduce the I-STOP sling to urologists, urogynecologists, and gynecologists in the United States. The sling has been successfully launched throughout Europe, the company said.
