Permacol Surgical Implant - Multi-purpose surgical mesh, collagen

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Compra

Commercializzato da:

Medtronic Australasia Pty Ltd

Classe:

Class III

Prodotto da:

Sofradim Production 116 Avenue du Formans, TREVOUX, 01600 France

Area terapeutica:

60907 - Multi-purpose surgical mesh, collagen

Indicazioni terapeutiche:

Permacol? Surgical Implant is a sterile, off-white, moist, tough and flexible, fibrous flat sheet of acellular porcine dermal collagen and its constituent elastin fibres. Presented moist in sterile saline, Permacol? Surgical Implant is double vacuum packed and heat sealed in peel-open aluminium foil (inner) and peel open polyester/polyethylene (outer)pouches, which are impermeable to oxygen and moisture. 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

Stato dell'autorizzazione:

A

Data dell'autorizzazione:

2016-02-10

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