Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart F — Obstetrical and Gynecological Therapeutic Devices](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices) → [21 CFR 884.5980](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5980) → OTP — Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed # OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed _Obstetrics/Gynecology · 21 CFR 884.5980 · Class 3_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP ## Overview - **Product Code:** OTP - **Device Name:** Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed - **Regulation:** [21 CFR 884.5980](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5980) - **Device Class:** 3 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) - **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](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K122459.md) | PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM | Boston Scientific Corporation | Dec 13, 2012 | SESE | | [K121612](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K121612.md) | ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION | American Medical Systems | Jul 20, 2012 | SESE | | [K112842](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K112842.md) | AMS ELEVATE PC | American Medical Systems, Inc. | Oct 25, 2011 | SESE | | [K103426](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K103426.md) | LITE PELVIC FLOOR REPAIR KITS | Boston Scientific Corp | Sep 14, 2011 | SESE | | [K112386](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K112386.md) | EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM | Coloplast Corp. | Sep 8, 2011 | SESE | | [K102815](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K102815.md) | SURELIFT PROLAPSE SYSTEM | Neomedic International | Jul 7, 2011 | SESE | | [K111118](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K111118.md) | AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | American Medical Systems | Jul 1, 2011 | SESE | | [K092207](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K092207.md) | RESTORELLE POLYPROPYLENE MESH | Mpathy Medical Devices, Inc. | Aug 4, 2009 | SESE | | [K091131](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K091131.md) | PELVIC FLOOR REPAIR SYSTEM | Boston Scientific | May 8, 2009 | SESE | | [K083499](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K083499.md) | EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS | Coloplast A/S | May 8, 2009 | SESE | | [K090713](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K090713.md) | 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](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K083722.md) | ASCEND | Caldera Medical, Inc. | Mar 31, 2009 | SESE | | [K083839](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K083839.md) | AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM | C.R. Bard, Inc. | Jan 15, 2009 | SESE | | [K082677](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K082677.md) | AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | American Medical Systems, Inc. | Dec 23, 2008 | SESE | | [K082387](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K082387.md) | 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](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K082730.md) | 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](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K081710.md) | APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE | American Medical Systems | Oct 15, 2008 | SESE | | [K082571](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K082571.md) | AVAULTA SUPPORT SYSTEM | C.R. Bard, Inc. | Sep 30, 2008 | SESE | | [K081048](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K081048.md) | PINNACLE PELVIC FLOOR REPAIR KIT II | Boston Scientific Corp | Aug 22, 2008 | SESE | | [K071512](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP/K071512.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OTP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com