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
|
|
Correspondent Contact |
RENEE MELLUM |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 06/04/2012 |
Decision Date | 09/07/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|