| Device Classification Name |
mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
|
|---|
| 510(K) Number |
K090713 |
|---|
| Device Name |
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP |
|---|
| Applicant |
| AMERICAN MEDICAL SYSTEMS, INC. |
| 10700 bren rd., west |
|
minnetonka,
MN
55343
|
|
| Contact |
denise thompson |
| Regulation Number | 878.3300
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 03/18/2009 |
|---|
| Decision Date | 04/02/2009 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Obstetrics/Gynecology
|
|---|
| Review Advisory Committee |
General & Plastic Surgery
|
|---|
| summary |
summary
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
