Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
|
510(k) Number |
K082387 |
Device Name |
APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM |
Applicant |
AMERICAN MEDICAL SYSTEMS |
10700 BREN ROAD WEST |
MINNETONKA,
MN
55416
|
|
Applicant Contact |
SARAH PETERSON |
Correspondent |
AMERICAN MEDICAL SYSTEMS |
10700 BREN ROAD WEST |
MINNETONKA,
MN
55416
|
|
Correspondent Contact |
SARAH PETERSON |
Regulation Number | 884.5980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/19/2008 |
Decision Date | 12/04/2008 |
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
|
|
|