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]
522 Application Number | Applicant Name | Device Name |
---|---|---|
PS120001 | Acell Inc | Acell ubm surgical mesh ml and mlplus |
PS120002 | American Medical Systems Inc. | Ams large pore polypropylene mesh |
PS120003 | American Medical Systems Inc. | Ams large pore polypropylene mesh |
PS120004 | American Medical Systems Inc. | Ams elevate anterior & apical prolapse repair system with intepro lite |
PS120005 | American Medical Systems Inc. | Ams elevate anterior & apical prolapse repair system with intepro lite |
PS120006 | American Medical Systems Inc. | Ams elevate apical and posterior prolapse repair system with intepro lite or intexen lp |
PS120007 | American Medical Systems Inc. | Ams elevate apical and posterior prolapse repair system with intepro lite or intexen lp |
PS120008 | American Medical Systems Inc. | Ams elevate apical and posterior prolapse repair system with intepro lite or intexen lp |
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 |
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 |
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 |
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 |
PS120013 | American Medical Systems Inc. | Apogee and perigee systems with pc coated intepro lite |
PS120014 | American Medical Systems Inc. | Elevate prolapse repair system with pc coated intepro lite- apical and posterior prolapse repair system anterior and ap |
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 |
PS120089 | American Medical Systems Inc. | Miniarc precise single-incision sling system |
PS120090 | American Medical Systems Inc. | Miniarc precise single-incision sling system |
PS120091 | American Medical Systems Inc. | Miniarc precise single-incision sling system |
PS120092 | American Medical Systems Inc. | Miniarc precise single-incision sling system |
PS120016 | BioVascular Inc. | Peri-guard cv peri-guard ocu-guard supple peri-guard peri-strips – sleeve peri-strips-strips peri-strips dry vasc |
PS120018 | BioVascular Inc. | Supple peri-guard pericardium |
PS120019 | BioVascular Inc. | Supple peri-guard pericardium |
PS120020 | BioVascular Inc. | Supple peri-guard pericardium |
PS120021 | Boston Scientific Corporation | Lite pelvic floor repair kits |
PS120022 | Boston Scientific Corporation | Pelvic floor repair system (pinnacle duet) |
PS120023 | Boston Scientific Corporation | Pinnacle pelvic floor repair kit ii (uphold) |
PS120024 | Boston Scientific Corporation | Pinnacle pelvic floor repair kits (pinnacle) |
PS120093 | Boston Scientific Corporation | Boston scientific surgical mesh (solyx sis) |
PS120025 | Brennen Medical Inc. | BRENNEN MEDICAL SURGICAL MESH GLUCAMESH/GLUCATEX |
PS120026 | Brennen Medical Inc. | DERMMATRIX SURGICAL MESH |
PS120027 | C.R. Bard Inc. | Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system |
PS120028 | C.R. Bard Inc. | Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system |
PS120029 | C.R. Bard Inc. | Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system |
PS120030 | C.R. Bard Inc. | Bard prolapse repair system |
PS120031 | C.R. Bard Inc. | Bard pelvisoft acellular collagen biomesh |
PS120094 | C.R. Bard Inc. | Ajust adjustable single incision sling |
PS120032 | Caldera Medical Inc. | POPMESH |
PS120033 | Caldera Medical Inc. | ASCEND BLUE AC MESH; ASCEND BLUE PC MESH |
PS120034 | Caldera Medical Inc. | ASCEND BLUE AC MESH; ASCEND BLUE PC MESH |
PS120035 | Coloplast Corp | Exair anterior and posterior prolapse repair systems |
PS120036 | Coloplast Corp | EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS |
PS120037 | Coloplast Corp | MENTOR NOVASILK MESH |
PS120038 | Coloplast Corp | RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH |
PS120055 | Coloplast Corp | MINIMESH POLYPROPYLENE MESH |
PS120056 | Coloplast Corp | MINIMESH POLYPROPYLENE MESH |
PS120096 | Coloplast Corp | GYNE IDEAS MINITAPE RP DEVICE |
PS120097 | Coloplast Corp | MINITAPE URETHRAL SLING |
PS120098 | Coloplast Corp | MINITAPE URETHRAL SLING |
PS120039 | Cook Biotech Inc. | Surgisis staple line reinforcement |
PS120040 | Cousin Biotech SARL | BIOMESH P1 AND BIOMESH PLUG AND PATCH |
PS120071 | Covidien | Parietene duo and quadra polypropylene meshes |
PS120072 | Covidien | Ugytex dual knit mesh |
PS120075 | Covidien | Permacol surgical implant t-piece permacol surgical implant rectocele-piece models 5928-150 5645-150 |
PS120076 | Covidien | Permacol surgical implant t-piece permacol surgical implant rectocele-piece models 5928-150 5645-150; Permacol surgical implant |
PS120041 | CryoLife Inc. | PROPATCH SOFT TISSUE REPAIR MATRIX |
PS120042 | CryoLife Inc. | Propatch soft tissue repair matrix |
PS120095 | Ethicon Inc. | Gynecare tvt secur system |
PS120043 | Ethicon Inc. | Gynecare prolift +m* pelvic floor repair systems |
PS120044 | Ethicon Inc. | Gynecare prosima pelvic floor repair systems |
PS120045 | Ethicon Inc. | Tbd ethicon mesh (gynecare gynemesh m) |
PS120046 | Ethicon Inc. | Gynemesh prolene soft (polypropylene) nonabsorbable synthetic surgical mesh for pelvic floor repair |
PS120053 | Herniamesh SRL | Pelvimesh / hermesh 7 |
PS120048 | Kensey Nash Corporation | BIOBLANKET SURGICAL MESH |
PS120049 | Kensey Nash Corporation | BIOBLANKET SURGICAL MESH |
PS120050 | Kensey Nash Corporation | MEDEOR MATRIX MODELS 30010-XX (HYDRATED); 30020-XX (DRY) |
PS120051 | Kensey Nash Corporation | Kensey nash ecm surgical patch |
PS120052 | Macropore Biosurgery Inc. | Macropore surgiwrap (ts) |
PS120054 | Mast Biosurgery USA Inc. | Surgi-wrap mast bioresorbable sheet |
PS120057 | Neomedic International | SURELIFT PROLAPSE SYSTEM |
PS120058 | Organogenesis Inc. | FORTAFLEX SURGICAL MESH |
PS120059 | Organogenesis Inc. | FORTAFLEX SURGICAL MESH |
PS120060 | Organogenesis Inc. | FORTAFLEX SURGICAL MESH |
PS120047 | PFM Medical | Timesh also known as timesh-tc models 6000001 & 6000004 |
PS120066 | Promethean Surgical Devices Inc. | HYDROCOAT MESH |
PS120099 | Prosurg Inc. | MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM (EASY LIFT PROLAPSE REPAIR & MINISLING) |
PS120067 | Proxy Biomedical Ltd. | POLYFORM SYNTHETIC MESH |
PS120068 | RTI Biologics Inc. | Tutopatch tutomesh |
PS120069 | Shelhigh Inc. | Shelhigh porcine pericardial patch |
PS120070 | Shelhigh Inc. | SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. |
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 |
PS120061 | Smith & Nephew Inc | Immix plastifilm |
PS120073 | Sofradim Production | Ugytex mesh |
PS120074 | Sofradim Production | Parietex |
PS120063 | Synovis Surgical Innovation | Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh |
PS120064 | Synovis Surgical Innovation | Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh |
PS120065 | Synovis Surgical Innovations | Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh |
PS120077 | Synovis Surgical Innovations | Veritas collagen matrix |
PS120078 | Synovis Surgical Innovations | Veritas collagen matrix |
PS120017 | Synovis Surgical Innovations | Peri-strips |
PS120080 | Tei Biosciences Inc. | TISSUEMEND SOFT TISSUE REPAIR MATRIX |
PS120081 | Tei Biosciences Inc. | XENFORM SOFT TISSUE REPAIR MATRIX |
PS120082 | Tei Biosciences Inc. | Xenform soft tissue repair matrix |
PS120079 | Tepha Inc. | Tephaflex surgical mesh |
PS120083 | W.L. Gore & Associates Inc. | Seamguard staple line reinforcement material |
PS120084 | W.L. Gore & Associates Inc. | Modification to seamguard staple line reinforcement material |
PS120085 | W.L. Gore & Associates Inc. | Gore bioabsorbable mesh |
PS120086 | W.L. Gore & Associates Inc. | Seamguard staple line reinforcement material |
PS120087 | Xylos Corporation | Xylos porous surgical mesh |
PS120088 | Xylos Corporation | Xylos porous surgical mesh |