The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System.
| Device ID | K211223 |
| 510k Number | K211223 |
| Device Name: | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Rachel Nankervis |
| Correspondent | Brooke Cuddy Boston Scientific 100 Boston Scientific Way Marlborough, MA 01564 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-23 |
| Decision Date | 2021-07-21 |