Product code SDB

Device name

Tracheal Prosthesis With Cover Material Derived From Human Sources

Medical specialty

Anesthesiology

Device class

2

Regulation number

868.3721

Review panel

AN

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset