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
|
|
Correspondent Contact |
NGOC LINH PHAM LATCHMAN |
Regulation Number | 884.5980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/01/2012 |
Decision Date | 07/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|