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Collagen Repair Patch is intended for the reinforcement of soft tissues which are repaired by sutures or suture anchors, during rotator cuff repair surgery. Collagen Repair Patch is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the rotator cuff repair. Collagen Repair Patch reinforces soft tissue and provides a scaffold that is eventually incorporated into the patients own soft tissue.

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Permacol® Surgical Implants are intended for use to support/reinforce soft tissue in surgical procedures. Permacol® Surgical Implant T-pieces are shaped for use in rectal intussusception repair and Permacol® Surgical Implant Rectocele-pieces are shaped for use in rectocele repair.

Permacol® T-piece and Permacol® Rectocele-piece are substantially equivalent to the predicate devices because they have the same intended uses and very similar technological characteristics.

Permacol® Surgical Implant is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.

Permacol® Surgical Implant Crosslinked Porcine Dermal Collagen Mesh

Permacol™ - Crosslinked Porcine Dermal Collagen Surgical Mesh ("Permacol™ ") is intended to be used for reinforcement of the soft tissues which are repaired by suture or suture anchors limited to the supraspinatus during rotator cuff repair surgery.

Permacol™ is available in sheet form.

Permacol™ is indicated for use to provide soft tissue repair or reinforcement in plastic and reconstructive surgery of the face and head. Permacol™ tissue is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue in plastic and reconstructive surgery of the face and head.

Permacol™ consists of a sterile, tough, off-white, moist, flexible, fibrous flat sheet comprised of acellular crosslinked porcine dermal collagen and elastin. Each impermeable inner pack contains a small quantity of saline to maintain its moistness and flexibility. The product is available in thicknesses of 0.5-1.5 mm and dimensions of 0.8 x 0.8 to 4 x 6 inches.

Permacol™ is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for use in the following types of soft tissue repair procedures: abdominal, inquinal, diaphragmatic, femoral, scrotal, . umbilical, and incisional hernias; . colon, rectal, urethral, and vaginal prolapse: muscle flap reinforcement; . . reconstruction of the pelvic floor; sacrocolposuspension; and . . urethral sling.

Permacol™ is a sterile, tough. off-white. moist. flexible, fibrous flat sheet solely comprised of acellular crosslinked porcine dermal collagen and elastin