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Biodesign Anal Fistula Plug: For implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal and enterocutaneous fistulas. Biodesign Fistula Plug: For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Biodesign Plastic Surgery Matrix: For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. Biodesign Tissue Graft: For implantation to reinforce soft tissue.

All four subject devices of this bundled submission are part of a family of devices manufactured by Cook Biotech Incorporated (CBI) consisting of processed porcine small intestinal submucosa (SIS), a three-dimensional, acellular, collagen-based extracellular matrix (ECM) material. SIS is manufactured by first removing the tunica mucosa from the inner intestinal surface and the serosa and tunica muscularis from the outer surface of the porcine small intestine. Further processing removes the cells and renders the material virally inactive. leaving behind a three- dimensional, decellularized, collagen-rich extracellular matrix.