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The Pinnacle LITE Pelvic Floor Repair Kit is indicated for tissue reinforcement in women with pelvic organ prolapse, for transvaginal repair of posterior vaginal vault prolapse. The Uphold LITE Vaginal Support System is indicated for tissue reinforcement in women with pelvic organ prolapse, for the transvaginal repair of anterior and apical vaginal wall prolapse.

The proposed devices were submitted for a leg assembly modification to the previously cleared LITE Pelvic Floor Repair Kits: Pinnacle LITE Posterior and Uphold LITE Vaginal Support System. The modification to the leg assembly removes the mesh tack welds, separator weld and adds a second leader loop to maintain the mesh leg location within the sleeve to facilitate mesh leg placement. There are no changes to the mesh design, shape, size, material or indications for use. The proposed mesh configurations were designed for performing transvaginal vaginal wall repair to facilitate treatment of anterior apical and posterior prolapse repairs. These devices are sterile, single use devices, consisting of one lightweight synthetic mesh assembly and a needle holder. The mesh assembly consists of a macroporous polypropylene knitted mesh body with integrated legs that are protected by disposable polymer sleeves. At the distal end of the disposable polymer sleeve is a lead with dart designed for use with the Capio™ Suture Capturing Device. The disposable lead was designed to facilitate the passage of the proposed mesh through bodily tissues for placement.

Elevate Anterior and Apical Prolapse Repair System The Elevate Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior wall prolapse and vaginal apical prolapse. Elevate Apical and Posterior Prolapse Repair System The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior wall prolapse and vaginal apical prolapse. Elevate Apical and Posterior Prolapse Repair System with InteXen® LP The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse.

Each Elevate System consists of a permanently-implanted graft and non-implantable surgical instruments that can be used as aids to transvaginally place the graft assembly in the pelvic floor. The graft assemblies for the Elevate Anterior & Apical Prolapse Repair System and Elevate Apical & Posterior Prolapse Repair System are made from polymeric mesh (IntePro Lite), and in the case of the Elevate Apical & Posterior Prolapse Repair System with InteXen LP, the graft assembly is made from a combination of lyophilized porcine dermis and polymeric mesh (IntePro Lite). The devices are identical to the predicate devices, AMS Elevate Prolapse Repair Systems, with the exception of the modification to the Apical Needle Passer Sheath. There are no changes to the implant graft design, shape, size, and material. The revisions to the indications for use of the modified devices are to further clarify the intended use of Elevate System as a kit for transvaginal surgical treatment.

AMS Elevate PC Anterior and Apical Prolapse Repair System with IntePro Lite: The Elevate PC Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement. AMS Elevate PC Apical and Posterior Prolapse Repair System with IntePro Lite: The Elevate PC Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.

The AMS Elevate PC Prolapse Repair Systems with IntePro Lite consist of a mesh assembly, non-implantable needle passers, and other surgical aids that are designed to help place the mesh assembly in the pelvic floor. The devices are identical to the predicate device AMS Elevate PC Prolapse Repair System with the following exception of the modification of the Apical Needle Passer Sheath. There are no changes to the mesh design, shape, size, material or Indications for Use.

The proposed LITE Pelvic Floor Repair Kits are indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The proposed devices were submitted to introduce lightweight versions of previously cleared pelvic floor repair kits: Pinnacle Anterior/Apical, Pinnacle Posterior, Pinnacle Duet and Uphold Vaginal Support System. The proposed mesh configurations were designed for performing transvaginal vaginal wall repair to facilitate treatment of anterior, apical and posterior prolapse repairs. These devices are sterile, single use devices, consisting of one or two light-weight synthetic mesh assemblies and a needle holder. The mesh assemblies consist of a macroporous polypropylene knitted mesh body with integrated legs that are protected by disposable polymer sleeves. At the distal end of the disposable polymer sleeve is a lead with needle designed for use with the Capio The Open Access Suture Capturing Device. The disposable lead was designed to facilitate the passage of the proposed mesh through bodily tissues for placement.

The Coloplast Exair Anterior and Posterior Prolapse Repair Systems are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The Exair Anterior and Posterior Prolapse Repair System is composed of NovaSilk mesh precut into shape with an enlarged or elongated body with four appendages extending out from the main body. The mesh arms for both Exair Anterior and Posterior Prolapse Repair Systems are sleeved in 2-mil thick polypropylene to facilitate arm implantation and positioning: sleeves are removed after proper placement of the implant is achieved. The system instrumentation includes a hollow introducer used to create a passage through the tissues and facilitate placement of the mesh arms, and four (4) anterior or two (2) posterior retrievers used to guide the mesh arms in place the tissues for positioning and fixating the mesh body. The system provided sterile and for single use only.

The SURELIFT PROLAPSE SYSTEM is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and posterior vaginal wall prolapse. The kit includes instrumentation for transvaginal placement.

The Surelift Prolapse System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and posterior vaginal wall prolapse. The kit includes instrumentation for transvaginal placement. The kit is composed by a monofilament polypropylene mesh, two anchors with sutures to fix the mesh at the sacrospinose ligament, two anchoring handles to place the anchors and four passers to place the mesh through the obturator foramens. The mesh has six fixation points (two posterior fixation points and four arms): - Two posterior fixation points that are fixed to the sacrospinose ligaments. - Two middle arms that are passed through the arcus tendineus. - Two anterior arms that are passed through the anterior part of the obturator foramen. When placing the mesh, these six fixation points can be adjusted by the surgeon to leave the mesh flat at the proper tension avoiding wrinkles.

The Elevate PC Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement. The Elevate PC Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.

The AMS Elevate PC Prolapse Repair Systems with IntePro Lite consist of a permanentlyimplanted synthetic mesh assembly, non-implantable needle passers, and other surgical aids that are designed to help place the mesh assembly in the pelvic floor. The devices is identical to the predicate device AMS Elevate Prolapse Repair System with PC Coated IntePro Lite, with the following exceptions: (1) The anterior needle passer has been modified to add a release mechanism on the handle; and (2) as a result of the anterior needle passer modifications, the connection interface for the tissue fixation elements of the anterior center graft that correspond with the anterior needle passer also changed. The geometry of the internal diameter and the base of the tissue fixation elements changed slightly to accommodate the new shape of the anterior needle tip. There are no changes to the mesh design, shape, size, or material.

RESTORELLE™ polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

Restorelle™ is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene. Restorelle™ polypropylene mesh is constructed using a warp-knit process to a unique design that permits the mesh to be cut into any desired shape or size without unraveling. It maintains excellent isotropic properties arising from its knitted construction. Restorelle™ polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability properties which permit the correct adaptation to the various stresses encountered in the body. The device is supplied sterile.

The Coloplast Exair Anterior and Posterior prolapse repair systems are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The Exair Anterior Prolapse Repair System is made of NovaSilk mesh precut into a shape with an enlarged body and four appendages extending out from the main body. The Exair Posterior Prolapse Repair System is made of NovaSilk mesh precut into a shape with an elongated body and two appendages extending out from the main body. The mesh arms for both Exair Anterior and Exair Posterior Prolapse Repair Systems are sleeved in 2-mil thick polyethylene to facilitate device arm implantation and positioning; sleeves are removed after proper placement of implant is achieved. The System instrumentation includes a hollow introducer used to create a passage through the tissues and facilitate placement of the mesh arms, and four (4) anterior or two (2) posterior retrievers used to guide the mesh arms into place through the (1) and for positioning and fixating the mesh body. The System is provided sterile and for single use only.

The proposed Pelvic Floor Repair System is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The proposed device is a sterile, single use kit, consisting of two synthetic mesh assemblies and a needle holder. Each mesh assembly consists of a polypropylene knitted mesh body with integrated legs that are protected by disposable polymer sleeves. At the distal end of the disposable polymer sleeve is a lead with needle designed for use with the Capio™ Open Access Suture Capturing Device. The disposable lead was designed to facilitate the passage of the proposed mesh through bodily tissues for placement. The proposed mesh configurations were designed for performing vaginal wall repair to facilitate treatment of anterior, apical and posterior prolapse repairs.