The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Elevate Prolapse Repair System With Pc Coated Intepro Lite- Apical And Posterior Prolapse Repair System, Anterior And Ap.
| Device ID | K090713 |
| 510k Number | K090713 |
| Device Name: | ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | Denise Thompson |
| Correspondent | Denise Thompson 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 | 2009-03-18 |
| Decision Date | 2009-04-02 |
| Summary: | summary |