OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Obstetrics/Gynecology · 21 CFR 884.5980 · Class 3
Overview
| Product Code | OTP |
|---|---|
| Device Name | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Regulation | 21 CFR 884.5980 |
| Device Class | Class 3 |
| Review Panel | Obstetrics/Gynecology |
| Implant | Yes |
Identification
Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (20 of 31)
Showing 20 most recent of 31 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K122459 | PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM | Boston Scientific Corporation | Dec 13, 2012 | SESE |
| K121612 | ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION | American Medical Systems | Jul 20, 2012 | SESE |
| K112842 | AMS ELEVATE PC | American Medical Systems, Inc. | Oct 25, 2011 | SESE |
| K103426 | LITE PELVIC FLOOR REPAIR KITS | Boston Scientific Corp | Sep 14, 2011 | SESE |
| K112386 | EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM | Coloplast Corp. | Sep 8, 2011 | SESE |
| K102815 | SURELIFT PROLAPSE SYSTEM | Neomedic International | Jul 7, 2011 | SESE |
| K111118 | AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | American Medical Systems | Jul 1, 2011 | SESE |
| K092207 | RESTORELLE POLYPROPYLENE MESH | Mpathy Medical Devices, Inc. | Aug 4, 2009 | SESE |
| K091131 | PELVIC FLOOR REPAIR SYSTEM | Boston Scientific | May 8, 2009 | SESE |
| K083499 | EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS | Coloplast A/S | May 8, 2009 | SESE |
| K090713 | ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP | American Medical Systems, Inc. | Apr 2, 2009 | SESE |
| K083722 | ASCEND | Caldera Medical, Inc. | Mar 31, 2009 | SESE |
| K083839 | AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM | C.R. Bard, Inc. | Jan 15, 2009 | SESE |
| K082677 | AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | American Medical Systems, Inc. | Dec 23, 2008 | SESE |
| K082387 | APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM | American Medical Systems | Dec 4, 2008 | SESE |
| K082730 | AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE | American Medical Systems, Inc. | Nov 26, 2008 | SESE |
| K081710 | APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE | American Medical Systems | Oct 15, 2008 | SESE |
| K082571 | AVAULTA SUPPORT SYSTEM | C.R. Bard, Inc. | Sep 30, 2008 | SESE |
| K081048 | PINNACLE PELVIC FLOOR REPAIR KIT II | Boston Scientific Corp | Aug 22, 2008 | SESE |
| K071512 | GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS | ETHICON, Inc. | May 15, 2008 | SESE |
Top Applicants
- American Medical Systems, Inc. — 9 clearances
- American Medical Systems — 4 clearances
- Boston Scientific Corp — 3 clearances
- C.R. Bard, Inc. — 3 clearances
- ETHICON, Inc. — 2 clearances
