Product code OTP

Device name: Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Medical specialty: Obstetrics/Gynecology
Device class: 3
Regulation number: 884.5980
Review panel: OB
Implant: Y
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Definition: 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
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K122459	PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM	Boston Scientific Corporation	2012-12-13
K121612	ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION	American Medical Systems	2012-07-20
K112842	AMS ELEVATE PC	American Medical Systems, Inc.	2011-10-25
K103426	LITE PELVIC FLOOR REPAIR KITS	Boston Scientific Corp	2011-09-14
K112386	EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM	Coloplast Corp.	2011-09-08
K102815	SURELIFT PROLAPSE SYSTEM	Neomedic International	2011-07-07
K111118	AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE	American Medical Systems	2011-07-01
K092207	RESTORELLE POLYPROPYLENE MESH	Mpathy Medical Devices, Inc.	2009-08-04
K091131	PELVIC FLOOR REPAIR SYSTEM	Boston Scientific	2009-05-08
K083499	EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS	Coloplast A/S	2009-05-08
K090713	ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP	American Medical Systems, Inc.	2009-04-02
K083722	ASCEND	Caldera Medical, Inc.	2009-03-31
K083839	AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM	C.R. Bard, Inc.	2009-01-15
K082677	AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE	American Medical Systems, Inc.	2008-12-23
K082387	APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM	American Medical Systems	2008-12-04
K082730	AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE	American Medical Systems, Inc.	2008-11-26
K081710	APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE	American Medical Systems	2008-10-15
K082571	AVAULTA SUPPORT SYSTEM	C.R. Bard, Inc.	2008-09-30
K081048	PINNACLE PELVIC FLOOR REPAIR KIT II	Boston Scientific Corp	2008-08-22
K071512	GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS	ETHICON, Inc.	2008-05-15
K080185	AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM	American Medical Systems, Inc.	2008-04-10
K072951	PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES	Sofradim Production	2007-12-19
K071957	PINNACLE PELVIC FLOOR REPAIR KITS	Boston Scientific Corp	2007-11-08
K063712	AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM	C.R. Bard, Inc.	2007-03-12
K063562	GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS	ETHICON, Inc.	2007-02-26
K053414	MENTOR NOVASILK MESH	Mentor Corp.	2005-12-27
K051503	UGYTEX SUAL KNIT MESH	Sofradim Production	2005-08-05
K040623	AMS PERIGEE SYSTEM	American Medical Systems, Inc.	2004-05-17
K040537	AMS APOGEE VAULT SUSPENSION SYSTEM	American Medical Systems, Inc.	2004-04-22
K040521	MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH	American Medical Systems, Inc.	2004-03-24

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00814723020050	Elevate	ENDO PHARMACEUTICALS INC.	2015-10-24
00814723020067	Elevate	ENDO PHARMACEUTICALS INC.	2015-10-24
05708932459433	Exair	Coloplast A/S	2015-10-22
05708932459457	Exair	Coloplast A/S	2015-10-22
08714729839200	Uphold™ LITE	BOSTON SCIENTIFIC CORPORATION	2015-09-24

Product code OTP

Related 510(k) Records#

Related GUDID Devices#