Device |
tracheal prosthesis with cover material derived from human sources |
Definition |
The tracheal prosthesis with cover material derived from human sources is an expandable tubular device made of a metal material covered with a human-sourced decellularized material. It is intended to be implanted to restore the structure and/or function of the trachea or tracheobronchial tree. This device may also include a device delivery system. This device type does not include products that are intended to promote regeneration, impede inflammatory cascades, and release growth factors. |
Product Code | SDB |
Regulation Number |
868.3721
|
Device Class |
2
|
|
|