510(k) Premarket Notification

• Device Classification Name: mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
• 510(K) Number: K082387
• Device Name: APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM
• Applicant: AMERICAN MEDICAL SYSTEMS; 10700 bren road west; minnetonka, MN 55416
• Contact: sarah peterson
• Regulation Number: 878.3300
• Classification Product Code: OTP
• Subsequent Product Code: PAI
• Date Received: 08/19/2008
• Decision Date: 12/04/2008
• 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