AMS APOGEE VAULT SUSPENSION SYSTEM

Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

AMERICAN MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Ams Apogee Vault Suspension System.

Pre-market Notification Details

Device IDK040537
510k NumberK040537
Device Name:AMS APOGEE VAULT SUSPENSION SYSTEM
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Applicant AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka,  MN  55343
ContactElsa A Linke
CorrespondentElsa A Linke
AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka,  MN  55343
Product CodeOTP  
CFR Regulation Number884.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2004-03-02
Decision Date2004-04-22
Summary:summary

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