The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support System.
| Device ID | K122459 |
| 510k Number | K122459 |
| Device Name: | PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Applicant | Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Michelle Berry |
| Correspondent | Michelle Berry Boston Scientific Corporation 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 | 2012-08-13 |
| Decision Date | 2012-12-13 |
| Summary: | summary |