The following data is part of a premarket notification filed by Promedon S.a. with the FDA for Ophira Mini Sling System.
| Device ID | K110420 |
| 510k Number | K110420 |
| Device Name: | OPHIRA MINI SLING SYSTEM |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling |
| Applicant | PROMEDON S.A. 221 ELLIS PARKWAY Piscataway, NJ 08854 |
| Contact | Stephanie Rais |
| Correspondent | Stephanie Rais PROMEDON S.A. 221 ELLIS PARKWAY Piscataway, NJ 08854 |
| Product Code | PAH |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-14 |
| Decision Date | 2012-05-08 |
| Summary: | summary |