The following data is part of a premarket notification filed by American Medical Systems with the FDA for Apogee And Perigee Systems With Pc Coated Intepro Lite.
| Device ID | K081710 |
| 510k Number | K081710 |
| Device Name: | APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Applicant | AMERICAN MEDICAL SYSTEMS 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | Denise Thompson |
| Correspondent | Denise Thompson AMERICAN MEDICAL SYSTEMS 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Product Code | OTP |
| CFR Regulation Number | 884.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-17 |
| Decision Date | 2008-10-15 |
| Summary: | summary |