510(k) K071957 ยท OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
PINNACLE PELVIC FLOOR REPAIR KITS
| Applicant | Boston Scientific Corp, Marlboro MA, US |
| Decision | Substantially Equivalent, Nov 8, 2007 |
| Received | Jul 16, 2007 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K071957
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2018 | Boston Scientific Corporation PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100.
Indicated for tissue reinforcement in women with pelvic organ prolapse. Terminated |
PWI | None listed |
| May 4, 2018 | Boston Scientific Corporation PFR Kit- Pinnacle, Posterior; Model #M0068317100.
Indicated for tissue reinforcement in women with pelvic organ prolapse. Terminated |
PWI | None listed |
| Aug 3, 2011 | Boston Scientific Corporation Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repair Kit--Posterior STERILE.
Boston Scientific, Corp.
Indicated for tissue reinforcement and stabilization of fa Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.