The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Modification To Ams Large Pore Polypropylene Mesh.
| Device ID | K040521 |
| 510k Number | K040521 |
| Device Name: | MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | Elsa A Linke |
| Correspondent | Elsa A Linke AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Product Code | OTP |
| CFR Regulation Number | 884.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-01 |
| Decision Date | 2004-03-24 |
| Summary: | summary |