The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Polyform Synthetic Mesh.
| Device ID | K171271 |
| 510k Number | K171271 |
| Device Name: | Polyform Synthetic Mesh |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Michelle Berry |
| Correspondent | Elizabeth Renken Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | OTO |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-01 |
| Decision Date | 2017-12-15 |
| Summary: | summary |