The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Ams Single Incision Sling System (sis-0).
| Device ID | K070065 |
| 510k Number | K070065 |
| Device Name: | AMS SINGLE INCISION SLING SYSTEM (SIS-0) |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | Brad Onstad |
| Correspondent | Brad Onstad AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Product Code | PAH |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-08 |
| Decision Date | 2007-03-01 |
| Summary: | summary |