OTP · Class III · 21 CFR 884.5980

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
1–24 of 31
Cleared Dec 13, 2012
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
K122459
Boston Scientific Corporation
Obstetrics & Gynecology · 122d
Cleared Oct 25, 2011
AMS ELEVATE PC
K112842
American Medical Systems, Inc.
Obstetrics & Gynecology · 26d
Cleared Sep 14, 2011
LITE PELVIC FLOOR REPAIR KITS
K103426
Boston Scientific Corp
Obstetrics & Gynecology · 296d
Cleared Sep 08, 2011
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
K112386
Coloplast Corp.
Obstetrics & Gynecology · 21d
Cleared May 08, 2009
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
K083499
Coloplast A/S
Obstetrics & Gynecology · 164d
Cleared May 08, 2009
PELVIC FLOOR REPAIR SYSTEM
K091131
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
K090713
American Medical Systems, Inc.
Obstetrics & Gynecology · 15d
Cleared Jan 15, 2009
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
K083839
C.R. Bard, Inc.
Obstetrics & Gynecology · 23d
Cleared Dec 23, 2008
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
K082677
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
K082730
American Medical Systems, Inc.
Obstetrics & Gynecology · 69d
Cleared Sep 30, 2008
AVAULTA SUPPORT SYSTEM
K082571
C.R. Bard, Inc.
Obstetrics & Gynecology · 25d
Cleared Aug 22, 2008
PINNACLE PELVIC FLOOR REPAIR KIT II
K081048
Boston Scientific Corp
Obstetrics & Gynecology · 130d
Cleared May 15, 2008
GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS
K071512
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
K080185
American Medical Systems, Inc.
Obstetrics & Gynecology · 76d
Cleared Dec 19, 2007
PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
K072951
Sofradim Production
Obstetrics & Gynecology · 62d
Cleared Nov 08, 2007
PINNACLE PELVIC FLOOR REPAIR KITS
K071957
Boston Scientific Corp
Obstetrics & Gynecology · 115d
Cleared Mar 12, 2007
AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
K063712
C.R. Bard, Inc.
Obstetrics & Gynecology · 88d
Cleared Feb 26, 2007
GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
K063562
Ethicon, Inc.
Obstetrics & Gynecology · 91d
Cleared Dec 27, 2005
MENTOR NOVASILK MESH
K053414
Mentor Corp.
Obstetrics & Gynecology · 20d
Cleared Aug 05, 2005
UGYTEX SUAL KNIT MESH
K051503
Sofradim Production
Obstetrics & Gynecology · 59d
Cleared May 17, 2004
AMS PERIGEE SYSTEM
K040623
American Medical Systems, Inc.
Obstetrics & Gynecology · 69d
Cleared Apr 22, 2004
AMS APOGEE VAULT SUSPENSION SYSTEM
K040537
American Medical Systems, Inc.
Obstetrics & Gynecology · 51d
Cleared Mar 24, 2004
MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH
K040521
American Medical Systems, Inc.
Obstetrics & Gynecology · 23d
Cleared Dec 31, 2003
AMS LARGE PORE POLYPROPYLENE MESH
K033636
American Medical Systems, Inc.
Obstetrics & Gynecology · 42d

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