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Article: Uroplasty gets approvable letter for SUI bulking agent.
- Article from:
- Medical Device Daily
- Article date:
- September 18, 2006
CopyrightCOPYRIGHT 2006 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Uroplasty gets approvable letter for SUI bulking agent
By KAREN YOUNG
Medical Device Daily Staff Writer
Uroplasty (Minnetonka, Minnesota) reported last week that it has received an approvable letter for its pre-market application (PMA) from the FDA for what would be the company?s third product on the market in the U.S., Macroplastique Implants, one of what is known as ?bulking agents? for stress urinary incontinence (SUI) in females.
It would add to its I-STOP Mid-Urethral Sling, also for SUI, it said.
?We?re thrilled around here,? David Kaysen, president/CEO of Uroplasty, told Medical Device Daily. ?It was a long time coming. ...