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American Medical Systems Holdings, Inc.

FDA clears minimally invasive treatment for bladder condition

Published in Food and Drug Law Weekly, June 25th, 2004

American Medical Systems Holdings, Inc., (AMMD) announced that its Perigee Cystocele Repair System has received U.S. Food and Drug Administration (FDA) 510(k) clearance.

The company also announced it will begin physician training on this system in preparation for commercial release later this year.

Perigee is the latest in a series of products American Medical Systems has developed to repair pelvic floor defects in women, joining the Apogee Vaginal Vault System, Straight-In Sacral Colpopexy System, IntePro Polypropelene Mesh and InteXen Porcine Dermal Matrix. With Perigee, helical needles are used to introduce a supportive mesh to correct for the...

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