Device Dossier
Permacol Surgical Implant - Multi-purpose surgical mesh, collagen
Device Dossier for Permacol Surgical Implant - Multi-purpose surgical mesh, collagen (Multi-purpose surgical mesh, collagen, Class III, sponsor…
- GMDN category: Multi-purpose surgical mesh, collagen
Intended purpose
Permacol™ surgical implant is intended for use as a soft tissue implant to reinforce soft tissue where weakness exists in surgical procedures involving: • Repair of primary ventral and incisional hernia with defect sizes > 2cm and defects at wound classification levels from II to IV (i.e., clean-contaminated, contaminated, or infected wounds) • Repair of primary ventral and incisional hernias where fascial closure is not possible in liver transplant patients • Eyelid surgery and prevention of Frey’s syndrome in surgical resection of parotid tumors • Pelvic floor reconstruction after abdominoperineal excision for cancer
Functional description
Permacol™ Surgical Implant is made of a sterile, off-white, moist, tough and flexible, fibrous flat sheet of crosslinked acellular porcine dermal collagen-based matrix. Presented moist in sterile saline, Permacol™ surgical implant is double vacuum packed, and heat sealed in peel-open foil (inner) and peel open polyester/polyethylene (outer) pouches.