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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
510(k) Number K080185
Device Name AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM
Original Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren rd., west
minnetonka,  MN  55343
Original Contact mona inman
Regulation Number878.3300
Classification Product Code
OTP  
Subsequent Product Code
PAI  
Date Received01/25/2008
Decision Date 04/10/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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