The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Advance Xp Male Sling.
| Device ID | K182169 |
| 510k Number | K182169 |
| Device Name: | AdVance XP Male Sling |
| Classification | Mesh, Surgical, For Stress Urinary Incontinence, Male |
| Applicant | Boston Scientific Corporation 10700 Bren Road West Minnetonka, MN 55343 |
| Contact | Kaitlyn Rainbow |
| Correspondent | Kaitlyn Rainbow Boston Scientific Corporation 10700 Bren Road West Minnetonka, MN 55343 |
| Product Code | OTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-10 |
| Decision Date | 2018-11-27 |
| Summary: | summary |