The following data is part of a premarket notification filed by American Medical Systems with the FDA for Apogee And Perigee Systems With Intepro Lite And Intexen Lp, Part Of The Ams; Pelvic Floor Repair System.
| Device ID | K082387 |
| 510k Number | K082387 |
| Device Name: | APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Applicant | AMERICAN MEDICAL SYSTEMS 10700 BREN ROAD WEST Minnetonka, MN 55416 |
| Contact | Sarah Peterson |
| Correspondent | Sarah Peterson AMERICAN MEDICAL SYSTEMS 10700 BREN ROAD WEST Minnetonka, MN 55416 |
| Product Code | OTP |
| CFR Regulation Number | 884.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-19 |
| Decision Date | 2008-12-04 |
| Summary: | summary |