FDA Product Code OTP: Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Tissue Reinforcement Of The Fibromuscular Layer Of The Pelvic Floor When Surgical Treatment Is Indicated; Procedures Include Anterior And Posterior Vaginal Wall Prolapse Repair And Vaginal Apical Or Uterine Prolapse Repair Performed Transvaginally
Leading manufacturers include American Medical Systems, Inc., C.R. Bard, Inc. and Boston Scientific Corp.
31
Total
31
Cleared
90d
Avg days
2003
Since
FDA 510(k) Cleared Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed Devices (Product Code OTP)
31 devices
Cleared
Dec 13, 2012
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
Boston Scientific Corporation
Obstetrics & Gynecology
122d
Cleared
Oct 25, 2011
AMS ELEVATE PC
American Medical Systems, Inc.
Obstetrics & Gynecology
26d
Cleared
Sep 14, 2011
LITE PELVIC FLOOR REPAIR KITS
Boston Scientific Corp
Obstetrics & Gynecology
296d
Cleared
Sep 08, 2011
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
Coloplast Corp.
Obstetrics & Gynecology
21d
Cleared
May 08, 2009
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
Coloplast A/S
Obstetrics & Gynecology
164d
Cleared
May 08, 2009
PELVIC FLOOR REPAIR SYSTEM
Boston Scientific
Obstetrics & Gynecology
18d
Cleared
Apr 02, 2009
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
American Medical Systems, Inc.
Obstetrics & Gynecology
15d
Cleared
Jan 15, 2009
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
C.R. Bard, Inc.
Obstetrics & Gynecology
23d
Cleared
Dec 23, 2008
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
American Medical Systems, Inc.
Obstetrics & Gynecology
99d
Cleared
Nov 26, 2008
AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE
American Medical Systems, Inc.
Obstetrics & Gynecology
69d
Cleared
Sep 30, 2008
AVAULTA SUPPORT SYSTEM
C.R. Bard, Inc.
Obstetrics & Gynecology
25d
Cleared
Aug 22, 2008
PINNACLE PELVIC FLOOR REPAIR KIT II
Boston Scientific Corp
Obstetrics & Gynecology
130d
Cleared
May 15, 2008
GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS
Ethicon, Inc.
Obstetrics & Gynecology
346d
Cleared
Apr 10, 2008
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM
American Medical Systems, Inc.
Obstetrics & Gynecology
76d
Cleared
Dec 19, 2007
PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
Sofradim Production
Obstetrics & Gynecology
62d
Cleared
Nov 08, 2007
PINNACLE PELVIC FLOOR REPAIR KITS
Boston Scientific Corp
Obstetrics & Gynecology
115d
Cleared
Mar 12, 2007
AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
C.R. Bard, Inc.
Obstetrics & Gynecology
88d
Cleared
Feb 26, 2007
GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
Ethicon, Inc.
Obstetrics & Gynecology
91d
Cleared
Dec 27, 2005
MENTOR NOVASILK MESH
Mentor Corp.
Obstetrics & Gynecology
20d
Cleared
Aug 05, 2005
UGYTEX SUAL KNIT MESH
Sofradim Production
Obstetrics & Gynecology
59d
Cleared
May 17, 2004
AMS PERIGEE SYSTEM
American Medical Systems, Inc.
Obstetrics & Gynecology
69d
Cleared
Apr 22, 2004
AMS APOGEE VAULT SUSPENSION SYSTEM
American Medical Systems, Inc.
Obstetrics & Gynecology
51d
Cleared
Mar 24, 2004
MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH
American Medical Systems, Inc.
Obstetrics & Gynecology
23d
Cleared
Dec 31, 2003
AMS LARGE PORE POLYPROPYLENE MESH
American Medical Systems, Inc.
Obstetrics & Gynecology
42d