The following data is part of a premarket notification filed by American Medical Systems with the FDA for Ams Large Pore Polyprophlene Mesh.
| Device ID | K121805 |
| 510k Number | K121805 |
| Device Name: | AMS LARGE PORE POLYPROPHLENE MESH |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Applicant | AMERICAN MEDICAL SYSTEMS 10700 BREN ROAD WEST Minnetonka, MN 55343 |
| Contact | Renee Mellum |
| Correspondent | Renee Mellum AMERICAN MEDICAL SYSTEMS 10700 BREN ROAD WEST Minnetonka, MN 55343 |
| Product Code | OTO |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-19 |
| Decision Date | 2012-10-16 |
| Summary: | summary |