MINIARC PRO SINGLE-INCISION SLING SYSTEM


Device Classification Name

mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling

510(k) Number K121641
Device Name MINIARC PRO SINGLE-INCISION SLING SYSTEM
Applicant
AMERICAN MEDICAL SYSTEMS
10700 bren road west
minnetonka, 
MN 
55343

Applicant Contact renee mellum
Correspondent
AMERICAN MEDICAL SYSTEMS
10700 bren road west
minnetonka, 
MN 
55343

Correspodent Contact renee mellum
Regulation Number 878.3300
Classification Product Code
PAH  
Date Received 06/04/2012
Decision Date 09/07/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No