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FDA Surveillance Studies of Urogynecologic Surgical Mesh

On January 3, 2012, the FDA ordered postmarket surveillance studies, known as "522 Studies," (Guidance for Industry and FDA Staff Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act) of urogynecologic surgical mesh.

Altogether, 99 studies were ordered, including 88 postmarket study orders from 33 manufacturers of urogynecologic surgical mesh for pelvic organ prolapse; and 11 postmarket study orders to seven manufacturers of single-incision mini-slings for stress urinary incontience.

The goal of these studies is to "provide the FDA, manufacturers, and health care providers with data that can inform the FDA's understanding of the safety and effectiveness profile of urogynecologic surgical mesh." [source]

Surgical Mesh: 522 Studies Requested by the FDA
522 Application Number Applicant Name Device Name Medical Specialty Root Document Number Date 522 Order Study Name Protocol Approved Study Population Study Status
PS120001 Acell Inc Acell ubm surgical mesh ml and mlplus General & Plastic Surgery K041140 1/3/2012 AE and effectiveness rates Other reason Other
PS120002 American Medical Systems Inc. Ams large pore polypropylene mesh Obstetrics/Gynecology K040521 1/3/2012 AE and effectiveness rates Other reason Other
PS120003 American Medical Systems Inc. Ams large pore polypropylene mesh 1/3/2012 AE and effectiveness rates Other reason Other
PS120004 American Medical Systems Inc. Ams elevate anterior & apical prolapse repair system with intepro lite General & Plastic Surgery K082677 1/3/2012 AE and effectiveness rates Plan Pending
PS120005 American Medical Systems Inc. Ams elevate anterior & apical prolapse repair system with intepro lite 1/3/2012 AE and effectiveness rates Other reason Other
PS120006 American Medical Systems Inc. Ams elevate apical and posterior prolapse repair system with intepro lite or intexen lp General & Plastic Surgery K082730 1/3/2012 AE and effectiveness rates Plan PendingElevate System w/InteXen LP
PS120007 American Medical Systems Inc. Ams elevate apical and posterior prolapse repair system with intepro lite or intexen lp 1/3/2012 AE and effectiveness rates Other reason Other
PS120008 American Medical Systems Inc. Ams elevate apical and posterior prolapse repair system with intepro lite or intexen lp 1/3/2012 AE and effectiveness rates Other reason Other
PS120009 American Medical Systems Inc. Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix ams apogee system with pre-connected collagen dermal matrix ams perigee system with pre-connected collagen dermal matrix 1/3/2012 Apogee and Perigee System w/IntePro Lite Study Pending
PS120010 American Medical Systems Inc. Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix ams apogee system with pre-connected collagen dermal matrix ams perigee system with pre-connected collagen dermal matrix 1/3/2012 Apogee AE and Eff Rates Study PendingPerigee AE and Eff Rates
PS120011 American Medical Systems Inc. Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix ams apogee system with pre-connected collagen dermal matrix ams perigee system with pre-connected collagen dermal matrix General & Plastic Surgery K040623 1/3/2012 AE and effectiveness rates Other reason Other
PS120012 American Medical Systems Inc. Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix ams apogee system with pre-connected collagen dermal matrix ams perigee system with pre-connected collagen dermal matrix General & Plastic Surgery K040623 1/3/2012 AE and effectiveness rates Other reason Other
PS120013 American Medical Systems Inc. Apogee and perigee systems with pc coated intepro lite General & Plastic Surgery K081710 1/3/2012 AE and effectiveness rates Other reason Other
PS120014 American Medical Systems Inc. Elevate prolapse repair system with pc coated intepro lite- apical and posterior prolapse repair system anterior and ap 1/3/2012 AE and effectiveness rates Other reason Other
PS120015 American Medical Systems Inc. Ams collagen dermal matrix ams apogee system with pre-connected collagen dermal matrix ams perigee system with pre-connected collagen dermal matrix Obstetrics/Gynecology K050445 1/3/2012 AE and effectiveness rates Other reason Other
PS120089 American Medical Systems Inc. Miniarc precise single-incision sling system General & Plastic Surgery K100807 1/3/2012 AE and effectiveness rates Plan Pending
PS120090 American Medical Systems Inc. Miniarc precise single-incision sling system General & Plastic Surgery K070065 1/3/2012 AE and effectiveness rates Other reason Other
PS120091 American Medical Systems Inc. Miniarc precise single-incision sling system General & Plastic Surgery K071902 1/3/2012 AE and effectiveness rates Plan Pending
PS120092 American Medical Systems Inc. Miniarc precise single-incision sling system General & Plastic Surgery K073703 1/3/2012 AE and effectiveness rates Plan Pending
PS120016 BioVascular Inc. Peri-guard cv peri-guard ocu-guard supple peri-guard peri-strips - sleeve peri-strips-strips peri-strips dry vasc Obstetrics/Gynecology K983162 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120018 BioVascular Inc. Supple peri-guard pericardium Obstetrics/Gynecology K961810 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120019 BioVascular Inc. Supple peri-guard pericardium Obstetrics/Gynecology K961811 1/3/2012 AE and effectiveness rates Other reason Other
PS120020 BioVascular Inc. Supple peri-guard pericardium Obstetrics/Gynecology K923657 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120021 Boston Scientific Corporation Lite pelvic floor repair kits 1/3/2012 AE and effectiveness rates Plan Pending
PS120022 Boston Scientific Corporation Pelvic floor repair system (pinnacle duet) General & Plastic Surgery K091131 1/3/2012 AE and effectiveness rates Plan Pending
PS120023 Boston Scientific Corporation Pinnacle pelvic floor repair kit ii (uphold) General & Plastic Surgery K081048 1/3/2012 AE and effectiveness rates Plan Pending
PS120024 Boston Scientific Corporation Pinnacle pelvic floor repair kits (pinnacle) General & Plastic Surgery K071957 1/3/2012 AE and effectiveness rates Plan Pending
PS120093 Boston Scientific Corporation Boston scientific surgical mesh (solyx sis) General & Plastic Surgery K081275 1/3/2012 AE and effectiveness rates Plan Pending
PS120025 Brennen Medical Inc. BRENNEN MEDICAL SURGICAL MESH GLUCAMESH/GLUCATEX 1/3/2012 AE and effectiveness rates Other reason Other
PS120026 Brennen Medical Inc. DERMMATRIX SURGICAL MESH General & Plastic Surgery K021160 1/3/2012 AE and effectiveness rates Other reason Other
PS120027 C.R. Bard Inc. Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system General & Plastic Surgery K083839 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120028 C.R. Bard Inc. Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system General & Plastic Surgery K063712 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120029 C.R. Bard Inc. Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system General & Plastic Surgery K082571 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120030 C.R. Bard Inc. Bard prolapse repair system Obstetrics/Gynecology K101922 1/3/2012 AE and effectiveness rates Other reason Terminated
PS120031 C.R. Bard Inc. Bard pelvisoft acellular collagen biomesh General & Plastic Surgery K031332 1/3/2012 AE and effectiveness rates Adult: >21;Other reason Other
PS120094 C.R. Bard Inc. Ajust adjustable single incision sling General & Plastic Surgery K092607 1/3/2012 AE and effectiveness rates Plan Pending
PS120032 Caldera Medical Inc. POPMESH General Hospital K083424 1/3/2012 AE and effectiveness rates Other reason Other
PS120033 Caldera Medical Inc. ASCEND BLUE AC MESH; ASCEND BLUE PC MESH General & Plastic Surgery K101462 1/3/2012 AE and effectiveness rates Plan Pending
PS120034 Caldera Medical Inc. ASCEND BLUE AC MESH; ASCEND BLUE PC MESH General & Plastic Surgery K083722 1/3/2012 AE and effectiveness rates Plan Pending
PS120035 Coloplast Corp Exair anterior and posterior prolapse repair systems 1/3/2012 AE and effectiveness rates Plan Pending
PS120036 Coloplast Corp EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS 1/3/2012 AE and effectiveness rates Plan Pending
PS120037 Coloplast Corp MENTOR NOVASILK MESH 1/3/2012 AE and effectiveness rates Plan Pending
PS120038 Coloplast Corp RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH 1/3/2012 AE and effectiveness rates Plan Pending
PS120055 Coloplast Corp MINIMESH POLYPROPYLENE MESH 1/3/2012 AE and effectiveness rates Plan Pending
PS120056 Coloplast Corp MINIMESH POLYPROPYLENE MESH 1/3/2012 AE and effectiveness rates Plan Pending
PS120096 Coloplast Corp GYNE IDEAS MINITAPE RP DEVICE 1/3/2012 AE and effectiveness rates Plan Pending
PS120097 Coloplast Corp MINITAPE URETHRAL SLING 1/3/2012 AE and effectiveness rates Plan Pending
PS120098 Coloplast Corp MINITAPE URETHRAL SLING 1/3/2012 AE and effectiveness rates Plan Pending
PS120039 Cook Biotech Inc. Surgisis staple line reinforcement Obstetrics/Gynecology K022044 1/3/2012 AE and effectiveness rates Other reason Other
PS120040 Cousin Biotech SARL BIOMESH P1 AND BIOMESH PLUG AND PATCH General & Plastic Surgery K002479 1/3/2012 AE and effectiveness rates Other reason Other
PS120071 Covidien Parietene duo and quadra polypropylene meshes General & Plastic Surgery K072951 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120072 Covidien Ugytex dual knit mesh General & Plastic Surgery K051503 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120075 Covidien Permacol surgical implant t-piece permacol surgical implant rectocele-piece models 5928-150 5645-150 General & Plastic Surgery K050355 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120076 Covidien Permacol surgical implant t-piece permacol surgical implant rectocele-piece models 5928-150 5645-150; Permacol surgical implant 1/3/2012 AE and effectiveness rates Adult: >21 Plan Pending
PS120041 CryoLife Inc. PROPATCH SOFT TISSUE REPAIR MATRIX 1/3/2012 AE and effectiveness rates
PS120042 CryoLife Inc. Propatch soft tissue repair matrix General & Plastic Surgery K101587 1/3/2012 AE and effectiveness rates Other reason Other
PS120095 Ethicon Inc. Gynecare tvt secur system General & Plastic Surgery K052401 1/3/2012 AE and effectiveness rates Plan Pending
PS120043 Ethicon Inc. Gynecare prolift +m* pelvic floor repair systems General & Plastic Surgery K071512 1/3/2012 AE and effectiveness rates Plan Pending
PS120044 Ethicon Inc. Gynecare prosima pelvic floor repair systems General & Plastic Surgery K063562 1/3/2012 AE and effectiveness rates Plan Pending
PS120045 Ethicon Inc. Tbd ethicon mesh (gynecare gynemesh m) General & Plastic Surgery K082216 1/3/2012 AE and effectiveness rates Plan Pending
PS120046 Ethicon Inc. Gynemesh prolene soft (polypropylene) nonabsorbable synthetic surgical mesh for pelvic floor repair General & Plastic Surgery K013718 1/3/2012 AE and effectiveness rates Plan Pending
PS120053 Herniamesh SRL Pelvimesh / hermesh 7 General & Plastic Surgery K070625 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120048 Kensey Nash Corporation BIOBLANKET SURGICAL MESH General & Plastic Surgery K061030 1/3/2012 AE and effectiveness rates Other reason Other
PS120049 Kensey Nash Corporation BIOBLANKET SURGICAL MESH 1/3/2012 AE and effectiveness rates Other reason Other
PS120050 Kensey Nash Corporation MEDEOR MATRIX MODELS 30010-XX (HYDRATED); 30020-XX (DRY) General & Plastic Surgery K091499 1/3/2012 AE and effectiveness rates Other reason Other
PS120051 Kensey Nash Corporation Kensey nash ecm surgical patch General & Plastic Surgery K094061 1/3/2012 AE and effectiveness rates Other reason Other
PS120052 Macropore Biosurgery Inc. Macropore surgiwrap (ts) General & Plastic Surgery K012025 1/3/2012 AE and effectiveness rates Other reason Other
PS120054 Mast Biosurgery USA Inc. Surgi-wrap mast bioresorbable sheet General & Plastic Surgery K050332 1/3/2012 AE and effectiveness rates Other reason Terminated
PS120057 Neomedic International SURELIFT PROLAPSE SYSTEM Obstetrics/Gynecology K102815 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120058 Organogenesis Inc. FORTAFLEX SURGICAL MESH 1/3/2012 AE and effectiveness rates
PS120059 Organogenesis Inc. FORTAFLEX SURGICAL MESH 1/3/2012 AE and effectiveness rates
PS120060 Organogenesis Inc. FORTAFLEX SURGICAL MESH 1/3/2012 AE and effectiveness rates
PS120047 PFM Medical Timesh also known as timesh-tc models 6000001 & 6000004 Obstetrics/Gynecology K031225 1/3/2012 AE and effectiveness rates Other reason Other
PS120066 Promethean Surgical Devices Inc. HYDROCOAT MESH 1/3/2012 AE and effectiveness rates
PS120099 Prosurg Inc. MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM (EASY LIFT PROLAPSE REPAIR & MINISLING) 1/3/2012 AE and effectiveness rates
PS120067 Proxy Biomedical Ltd. POLYFORM SYNTHETIC MESH Obstetrics/Gynecology K051245 1/3/2012 AE and effectiveness rates Other reason Other
PS120068 RTI Biologics Inc. Tutopatch tutomesh Obstetrics/Gynecology K070894 1/3/2012 AE and effectiveness rates Other reason Other
PS120069 Shelhigh Inc. Shelhigh porcine pericardial patch 1/3/2012 AE and effectiveness rates
PS120070 Shelhigh Inc. SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. 1/3/2012 AE and effectiveness rates
PS120062 Smith & Nephew Immix thin film models: Pss-004-s pss-004-sp pss-004-m pss-004-mp pss-004-l pss-004-lp General & Plastic Surgery K032673 1/3/2012 AE and effectiveness rates Other reason Other
PS120061 Smith & Nephew Inc Immix plastifilm General & Plastic Surgery K024199 1/3/2012 AE and effectiveness rates Other reason Other
PS120073 Sofradim Production Ugytex mesh General & Plastic Surgery K033376 1/3/2012 AE and effectiveness rates Other reason Other
PS120074 Sofradim Production Parietex Obstetrics/Gynecology K982532 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120063 Synovis Surgical Innovation Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh Obstetrics/Gynecology K090288 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120064 Synovis Surgical Innovation Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh Obstetrics/Gynecology K071065 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120065 Synovis Surgical Innovations Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120077 Synovis Surgical Innovations Veritas collagen matrix General & Plastic Surgery K062915 1/3/2012 AE and effectiveness rates Adult: >21 Plan Pending
PS120078 Synovis Surgical Innovations Veritas collagen matrix General & Plastic Surgery K030879 1/3/2012 AE and effectiveness rates Adult: >21 Plan Pending
PS120017 Synovis Surgical Innovations Peri-strips Obstetrics/Gynecology K940205 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120080 Tei Biosciences Inc. TISSUEMEND SOFT TISSUE REPAIR MATRIX 1/3/2012 AE and effectiveness rates
PS120081 Tei Biosciences Inc. XENFORM SOFT TISSUE REPAIR MATRIX General & Plastic Surgery K060984 1/3/2012 AE and effectiveness rates Plan Pending
PS120082 Tei Biosciences Inc. Xenform soft tissue repair matrix Physical Medicine K024055 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120079 Tepha Inc. Tephaflex surgical mesh Obstetrics/Gynecology K070894 1/3/2012 AE and effectiveness rates Other reason Other
PS120083 W.L. Gore & Associates Inc. Seamguard staple line reinforcement material General & Plastic Surgery K955364 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120084 W.L. Gore & Associates Inc. Modification to seamguard staple line reinforcement material General & Plastic Surgery K001789 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120085 W.L. Gore & Associates Inc. Gore bioabsorbable mesh General & Plastic Surgery K033671 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120086 W.L. Gore & Associates Inc. Seamguard staple line reinforcement material General & Plastic Surgery K010936 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120087 Xylos Corporation Xylos porous surgical mesh General & Plastic Surgery K090880 1/3/2012 AE and effectiveness rates Device not marketed Other
PS120088 Xylos Corporation Xylos porous surgical mesh General & Plastic Surgery K081882 1/3/2012 AE and effectiveness rates Device not marketed Other
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