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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 K112842
Device Name AMS ELEVATE PC
Applicant
American Medical Systems, Inc.
10700 Bren Rd. W
Minnetonka,  MN  55343
Applicant Contact MATTHEW D STEPANEK
Correspondent
American Medical Systems, Inc.
10700 Bren Rd. W
Minnetonka,  MN  55343
Correspondent Contact MATTHEW D STEPANEK
Regulation Number884.5980
Classification Product Code
OTP  
Date Received09/29/2011
Decision Date 10/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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