RETROARC RETROPUBIC 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 Retroarc Retropubic Sling System.

Pre-market Notification Details

• Device ID: K132655
• 510k Number: K132655
• Device Name: RETROARC RETROPUBIC SLING SYSTEM
• Classification: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
• Applicant: AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343
• Contact: Renee Mellum
• Correspondent: Renee Mellum; AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343
• Product Code: OTN
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-08-26
• Decision Date: 2013-11-20
• Summary: summary