510(k) K081048 ยท OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
PINNACLE PELVIC FLOOR REPAIR KIT II
| Applicant | Boston Scientific Corp, Marlboro MA, US |
| Decision | Substantially Equivalent, Aug 22, 2008 |
| Received | Apr 14, 2008 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K081048
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2018 | Boston Scientific Corporation Uphold Vaginal Support System; Model #M0068317080.
Indicated for tissue reinforcement in women with pelvic organ prolapse. Terminated |
PWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.