Device Classification Name |
mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
|
510(k) Number |
K111118 |
Device Name |
AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE |
Applicant |
AMERICAN MEDICAL SYSTEMS |
10700 BREN RD WEST |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
MONA INMAN |
Correspondent |
AMERICAN MEDICAL SYSTEMS |
10700 BREN RD WEST |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
MONA INMAN |
Regulation Number | 884.5980
|
Classification Product Code |
|
Date Received | 04/21/2011 |
Decision Date | 07/01/2011 |
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
|
|
|