ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION


Device Classification Name

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

510(k) Number K121612
Device Name ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION
Applicant
AMERICAN MEDICAL SYSTEMS
10700 bren road west
minnetonka, 
MN 
55343

Applicant Contact ngoc linh pham latchman
Correspondent
AMERICAN MEDICAL SYSTEMS
10700 bren road west
minnetonka, 
MN 
55343

Correspodent Contact ngoc linh pham latchman
Regulation Number 878.3300
Classification Product Code
OTP  
Subsequent Product Code
PAI  
Date Received 06/01/2012
Decision Date 07/20/2012
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