SPARC SLING SYSTEM

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

AMERICAN MEDICAL SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK011251
510k NumberK011251
Device Name:SPARC SLING SYSTEM
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Applicant AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka,  MN  55343
ContactGinger S Glaser
CorrespondentGinger S Glaser
AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka,  MN  55343
Product CodeOTN  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-24
Decision Date2001-08-01

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