AMS MINIARC SLING SYSTEM

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling

AMERICAN MEDICAL SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK073703
510k NumberK073703
Device Name:AMS MINIARC SLING SYSTEM
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
Applicant AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka,  MN  55343
ContactBrad Onstad
CorrespondentBrad Onstad
AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka,  MN  55343
Product CodePAH  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-31
Decision Date2008-01-30
Summary:summary

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