510(k) Premarket Notification

• Device Classification Name: mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
• 510(K) Number: K082677
• Device Name: AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
• Applicant: AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd., west; minnetonka, MN 55343
• Contact: mona inman
• Regulation Number: 878.3300
• Classification Product Code: OTP
• Date Received: 09/15/2008
• Decision Date: 12/23/2008
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Obstetrics/Gynecology
• Review Advisory Committee: General & Plastic Surgery
• summary: summary
• Type: Special
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No