The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Gynecare Prosima Pelvic Floor Repair Systems.
| Device ID | K063562 |
| 510k Number | K063562 |
| Device Name: | GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Applicant | ETHICON, INC. P.O. BOX 151 ROUTE 22 WEST Somerville, NJ 08876 |
| Contact | Patrice Nagoda |
| Correspondent | Patrice Nagoda ETHICON, INC. P.O. BOX 151 ROUTE 22 WEST Somerville, NJ 08876 |
| Product Code | OTP |
| CFR Regulation Number | 884.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-27 |
| Decision Date | 2007-02-26 |
| Summary: | summary |