The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Lite Pelvic Floor Repair Kits.
| Device ID | K103426 |
| 510k Number | K103426 |
| Device Name: | LITE PELVIC FLOOR REPAIR KITS |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Applicant | BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Michelle Berry |
| Correspondent | Michelle Berry BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | OTP |
| CFR Regulation Number | 884.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-22 |
| Decision Date | 2011-09-14 |
| Summary: | summary |