OTPFDA Class 3 · 21 CFR 884.5980 · implantable
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Device family · Obstetrics/Gynecology
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
31
Manufacturers
11
Flagged signals
16
Adverse-event reports
11,865
Code matrix
| FDA product code | OTP |
| Device class | Class 3 |
| Regulation | 21 CFR 884.5980 |
| GMDN | — (crosswalk pending) |
| Implantable | Yes |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2017 | 4 | 16.9 | 45 |
| Death | 2016 | 21 | 14.0 | 243 |
| Other | 2016 | 3 | 12.7 | 22 |
| Death | 2015 | 37 | 6.6 | 172 |
| Death | 2007 | 9 | 6.0 | 33 |
| Death | 2008 | 7 | 4.7 | 17 |
| Death | 2010 | 7 | 4.7 | 17 |
| Death | 2011 | 19 | 3.4 | 30 |
| Death | 2009 | 5 | 3.3 | 6 |
| Death | 2012 | 16 | 2.9 | 18 |
| Death | 2010 | 16 | 2.9 | 18 |
| Death | 2014 | 15 | 2.7 | 14 |
| Injury | 2013 | 12 | 2.6 | 17 |
| Injury | 2013 | 1,143 | 2.6 | 1,774 |
| Injury | 2013 | 206 | 2.4 | 283 |
| Injury | 2013 | 126 | 2.1 | 115 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 3 family · 11,865 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| AMERICAN MEDICAL SYSTEMS, INC. | 9 | 2011 | — |
| C.R. Bard, Inc. | 3 | 2009 | — |
| Boston Scientific Corp | 3 | 2011 | — |
| Ethicon, Inc. | 2 | 2008 | — |
| SOFRADIM PRODUCTION | 2 | 2007 | — |
| Caldera Medical, Inc. | 1 | 2009 | — |
| Boston Scientific | 1 | 2009 | — |
| Coloplast A/S | 1 | 2009 | — |
| BOSTON SCIENTIFIC CORPORATION | 1 | 2012 | 0.14 |
| COLOPLAST CORP. | 1 | 2011 | — |
| Mentor Corp. | 1 | 2005 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM · Boston Scientific Corporation510(k) · 2012-12-13
ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION · American Medical Systems510(k) · 2012-07-20
AMS ELEVATE PC · American Medical Systems, Inc.510(k) · 2011-10-25
LITE PELVIC FLOOR REPAIR KITS · Boston Scientific Corp510(k) · 2011-09-14
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM · Coloplast Corp.510(k) · 2011-09-08
SURELIFT PROLAPSE SYSTEM · Neomedic International510(k) · 2011-07-07
AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE · American Medical Systems510(k) · 2011-07-01
RESTORELLE POLYPROPYLENE MESH · Mpathy Medical Devices, Inc.510(k) · 2009-08-04
PELVIC FLOOR REPAIR SYSTEM · Boston Scientific510(k) · 2009-05-08
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS · Coloplast A/S510(k) · 2009-05-08
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP · American Medical Systems, Inc.510(k) · 2009-04-02
ASCEND · Caldera Medical, Inc.510(k) · 2009-03-31
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM · C.R. Bard, Inc.510(k) · 2009-01-15
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE · American Medical Systems, Inc.510(k) · 2008-12-23
APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM · American Medical Systems510(k) · 2008-12-04
AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE · American Medical Systems, Inc.510(k) · 2008-11-26
APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE · American Medical Systems510(k) · 2008-10-15
AVAULTA SUPPORT SYSTEM · C.R. Bard, Inc.510(k) · 2008-09-30
PINNACLE PELVIC FLOOR REPAIR KIT II · Boston Scientific Corp510(k) · 2008-08-22
GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS · ETHICON, Inc.510(k) · 2008-05-15
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM · American Medical Systems, Inc.510(k) · 2008-04-10
PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES · Sofradim Production510(k) · 2007-12-19
PINNACLE PELVIC FLOOR REPAIR KITS · Boston Scientific Corp510(k) · 2007-11-08
AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM · C.R. Bard, Inc.510(k) · 2007-03-12
GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS · ETHICON, Inc.510(k) · 2007-02-26
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.