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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 K040537
Device Name AMS APOGEE VAULT SUSPENSION SYSTEM
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA,  MN  55343
Applicant Contact ELSA A LINKE
Correspondent
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA,  MN  55343
Correspondent Contact ELSA A LINKE
Regulation Number884.5980
Classification Product Code
OTP  
Date Received03/02/2004
Decision Date 04/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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