AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM


Device Classification Name

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

510(k) Number K080185
Device Name AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren rd., west
minnetonka, 
MN 
55343

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

Correspodent Contact mona inman
Regulation Number 878.3300
Classification Product Code
OTP  
Subsequent Product Code
PAI  
Date Received 01/25/2008
Decision Date 04/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No