Device Dossier
Biodesign Otologic repair Graft - Multi-purpose surgical mesh, collagen
Device Dossier for Biodesign Otologic repair Graft - Multi-purpose surgical mesh, collagen (Multi-purpose surgical mesh, collagen, Class III, sponsor…
- GMDN category: Multi-purpose surgical mesh, collagen
- Sponsor: Endotherapeutics
Intended purpose
The Biodesign Otologic repair Graft is intended for use as an implant to aid in surgical repairs and as an adjunct to aid in the natural healing process in otologic procedures. It is indicated for use in myringoplasty and tympanoplasty procedures
Functional description
The graft's natural extracellular collagen matrix is remodelled and replaced by the patient's own tissue, forming a permanent repair.