AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE


Device Classification Name

mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed

510(k) Number K111118
Device Name AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
Applicant
AMERICAN MEDICAL SYSTEMS
10700 bren rd west
minnetonka, 
MN 
55343

Applicant Contact mona inman
Correspondent
AMERICAN MEDICAL SYSTEMS
10700 bren rd west
minnetonka, 
MN 
55343

Correspodent Contact mona inman
Regulation Number 878.3300
Classification Product Code
OTP  
Date Received 04/21/2011
Decision Date 07/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No