FDA Clearance #:Manufacturer:Device Name:SubmissionClearance Predicate Devices:Predicate Devices - II:Predicate Devices - III:Notes:
Date:Date:
K962530Ethicon - Johnson & JohnsonModified Prolene6/25/19968/9/1996Preamendment Predicate K974098Ethicon - Johnson & JohnsonTension Free Transvaginal Taping (TVT) Device 10/30/19971/28/1998K963226 - ProteGen K001122Ethicon - Johnson & JohnsonProlene Soft (Polypropylene) Mesh - Modified4/6/20005/23/2000Preamendment Predicate K002672Ethicon - Johnson & JohnsonVYPRO Mesh8/25/200011/22/2000Preamendment Predicate (Used for Hernia and other Fascial Defects)K013718Ethicon - Johnson & JohnsonGynecare Gynemesh PS Prolene Soft Mesh11/6/200111/5/2012K001122, K962530, MersilenePreamendment Predicate (Used for Hernia and other Fascial Deficiencies)K031925Ethicon - Johnson & JohnsonProceed Surgical Mesh6/20/20039/17/2013Prolene SoftPreamendment Predicate K033337Ethicon - Johnson & JohnsonUltraspro Mesh1/8/20044/1/2004Vypro, Prolene & Mersilene (Used for Hernia and other Fascial Deficiencies)K033568Ethicon - Johnson & JohnsonGynecare TVT Obturator11/10/200312/8/2003K974098 - TVTK963226 - ProteGen K052401Ethicon - Johnson & JohnsonGynecare TVT Secur10/25/200511/28/2005K974098, K033568K963226 - ProteGen K060713Ethicon - Johnson & JohnsonProceed Surgical Mesh5/10/29965/26/2006Proceed Trilaminate Surgical Mesh??? K063562Ethicon - Johnson & JohnsonGynecare Prosima Pelvic Floor Repair System1/25/20072/26/2007K013718, etal K071512Ethicon - Johnson & JohnsonGynecare Prolift +M Pelvic Floor Repair System2/22/20085/15/2008K040537,K040623, etalSee Above K082216Ethicon - Johnson & JohnsonEthicon Mesh TBD8/4/20089/5/2008K071512, K013718See Above K093932Ethicon - Johnson & JohnsonEthicon Physiomesh3/19/20104/9/2010K031925, K060713, K071249 & K033337 (Used for Hernia and other Fascial Deficiencies)K100485Ethicon - Johnson & JohnsonGynecare TVT Exact2/18/20103/16/2010K974098 - TVTK963226 - ProteGen K100936Ethicon - Johnson & JohnsonGynecare TVT Abbrevo Continence System4/2/20107/1/2010K033568K974098-TVTK963226 - ProteGen K113205Ethicon - Johnson & JohnsonArtisyn Y Shaped Mesh1/13/20126/12/2012K082216 - Ethicon Mesh TBDSee Above K132054Ethicon - Johnson & JohnsonGynecare TVT Exact7/25/20138/23/2013K100485 - Gynecare TVT ExactK974098-TVTK963226 - ProteGen
From Medicine Net.com
Medical Definition of Fascial: A flat band of tissue below the skin that covers underlying tissues and separates different layers of tissue. Fascia also encloses muscles.
From Obstetrics and Gynecology: http://journals.lww.com/greenjournal/Fulltext/2001/11000/Histologic_Examination_of__Fascia__Used_in.15.aspx
In patients undergoing primary anterior and posterior colporrhaphy, biopsies were taken from three surgically distinct vaginal tissues types: the wall, the “fascia,” and areolar tissue
(Meaning,at least one component of the make up of the vagina is facial, and therefore any device listed above that state they are used for hernias and other fascial deficiencies could
technically be used for bladder repair as well)
** Please note - At least five of the meshes above have been cleared through the FDA based upon predicate devices based upon the recalled Protegen Sling. The ProteGen Sling manufactured
by Boston Scientific was recalled from the market on 3/17/1999, by the manufacturer itself, and the reason stated was "Use of the ProteGen in the treatment of female urinary incontinence is
associated with a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.”
Research by: Suzanne McClain
Date:Date:
K962530Ethicon - Johnson & JohnsonModified Prolene6/25/19968/9/1996Preamendment Predicate K974098Ethicon - Johnson & JohnsonTension Free Transvaginal Taping (TVT) Device 10/30/19971/28/1998K963226 - ProteGen K001122Ethicon - Johnson & JohnsonProlene Soft (Polypropylene) Mesh - Modified4/6/20005/23/2000Preamendment Predicate K002672Ethicon - Johnson & JohnsonVYPRO Mesh8/25/200011/22/2000Preamendment Predicate (Used for Hernia and other Fascial Defects)K013718Ethicon - Johnson & JohnsonGynecare Gynemesh PS Prolene Soft Mesh11/6/200111/5/2012K001122, K962530, MersilenePreamendment Predicate (Used for Hernia and other Fascial Deficiencies)K031925Ethicon - Johnson & JohnsonProceed Surgical Mesh6/20/20039/17/2013Prolene SoftPreamendment Predicate K033337Ethicon - Johnson & JohnsonUltraspro Mesh1/8/20044/1/2004Vypro, Prolene & Mersilene (Used for Hernia and other Fascial Deficiencies)K033568Ethicon - Johnson & JohnsonGynecare TVT Obturator11/10/200312/8/2003K974098 - TVTK963226 - ProteGen K052401Ethicon - Johnson & JohnsonGynecare TVT Secur10/25/200511/28/2005K974098, K033568K963226 - ProteGen K060713Ethicon - Johnson & JohnsonProceed Surgical Mesh5/10/29965/26/2006Proceed Trilaminate Surgical Mesh??? K063562Ethicon - Johnson & JohnsonGynecare Prosima Pelvic Floor Repair System1/25/20072/26/2007K013718, etal K071512Ethicon - Johnson & JohnsonGynecare Prolift +M Pelvic Floor Repair System2/22/20085/15/2008K040537,K040623, etalSee Above K082216Ethicon - Johnson & JohnsonEthicon Mesh TBD8/4/20089/5/2008K071512, K013718See Above K093932Ethicon - Johnson & JohnsonEthicon Physiomesh3/19/20104/9/2010K031925, K060713, K071249 & K033337 (Used for Hernia and other Fascial Deficiencies)K100485Ethicon - Johnson & JohnsonGynecare TVT Exact2/18/20103/16/2010K974098 - TVTK963226 - ProteGen K100936Ethicon - Johnson & JohnsonGynecare TVT Abbrevo Continence System4/2/20107/1/2010K033568K974098-TVTK963226 - ProteGen K113205Ethicon - Johnson & JohnsonArtisyn Y Shaped Mesh1/13/20126/12/2012K082216 - Ethicon Mesh TBDSee Above K132054Ethicon - Johnson & JohnsonGynecare TVT Exact7/25/20138/23/2013K100485 - Gynecare TVT ExactK974098-TVTK963226 - ProteGen
From Medicine Net.com
Medical Definition of Fascial: A flat band of tissue below the skin that covers underlying tissues and separates different layers of tissue. Fascia also encloses muscles.
From Obstetrics and Gynecology: http://journals.lww.com/greenjournal/Fulltext/2001/11000/Histologic_Examination_of__Fascia__Used_in.15.aspx
In patients undergoing primary anterior and posterior colporrhaphy, biopsies were taken from three surgically distinct vaginal tissues types: the wall, the “fascia,” and areolar tissue
(Meaning,at least one component of the make up of the vagina is facial, and therefore any device listed above that state they are used for hernias and other fascial deficiencies could
technically be used for bladder repair as well)
** Please note - At least five of the meshes above have been cleared through the FDA based upon predicate devices based upon the recalled Protegen Sling. The ProteGen Sling manufactured
by Boston Scientific was recalled from the market on 3/17/1999, by the manufacturer itself, and the reason stated was "Use of the ProteGen in the treatment of female urinary incontinence is
associated with a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.”
Research by: Suzanne McClain