The following data is part of a premarket notification filed by American Medical Systems with the FDA for Elevate Prolapse Repair Systems-apical Needle Passer Sheath Modification.
| Device ID | K121612 |
| 510k Number | K121612 |
| Device Name: | ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Applicant | AMERICAN MEDICAL SYSTEMS 10700 BREN ROAD WEST Minnetonka, MN 55343 |
| Contact | Ngoc Linh Pham Latchman |
| Correspondent | Ngoc Linh Pham Latchman AMERICAN MEDICAL SYSTEMS 10700 BREN ROAD 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 | 2012-06-01 |
| Decision Date | 2012-07-20 |
| Summary: | summary |