FDA Product Code OTO: Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Bridging Material To Attach The Vaginal Apex To The Anterior Longitudinal Ligament Of The Sacrum; Procedures Include Abdominal Sacrocolpopexy And Laparoscopic Sacrocolpopexy.
Leading manufacturers include Coloplast A/S, Coloplast Corp. and American Medical Systems, Inc..
23
Total
23
Cleared
120d
Avg days
2001
Since
FDA 510(k) Cleared Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed Devices (Product Code OTO)
23 devices
Cleared
Dec 15, 2017
Polyform Synthetic Mesh
Boston Scientific Corporation
Obstetrics & Gynecology
228d
Cleared
Feb 12, 2014
RESTORELLE Y CONTOUR MESH
Coloplast A/S
Obstetrics & Gynecology
27d
Cleared
Aug 02, 2013
RESTORELLE M, RESTORELLE XL
Coloplast Corp.
Obstetrics & Gynecology
30d
Cleared
Mar 05, 2013
RESTORELLE Y CONTOUR
Coloplast A/S
Obstetrics & Gynecology
76d
Cleared
Dec 18, 2012
UPSYLON Y MESH
Boston Scientific Corp
Obstetrics & Gynecology
97d
Cleared
Dec 18, 2012
NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
Coloplast Corp.
Obstetrics & Gynecology
84d
Cleared
Nov 19, 2012
RESTORELLE L
Coloplast Corp.
Obstetrics & Gynecology
101d
Cleared
Jun 11, 2012
ARTISYN Y-SHAPED MESH
Ethicon, Inc.
Obstetrics & Gynecology
224d
Cleared
May 17, 2012
RESTORELLE POLYPROPYLENE Y MESH
Coloplast A/S
Obstetrics & Gynecology
279d
Cleared
Apr 01, 2011
ALYTE Y-MESH GRAFT
C.R. Bard, Inc.
Obstetrics & Gynecology
287d
Cleared
Nov 10, 2009
BARD SACROCOLPOPEXY GRAFT
C.R. Bard, Inc.
Obstetrics & Gynecology
235d
Cleared
Aug 03, 2005
AMS PELVIC FLOOR REPAIR SYSTEM
American Medical Systems, Inc.
Obstetrics & Gynecology
58d
Cleared
Apr 09, 2001
AMS SACRAL COLPOPEXY SLING, MODEL 72403501
American Medical Systems, Inc.
Obstetrics & Gynecology
12d