21 CFR 868.3721 — Tracheal Prosthesis With Cover Material Derived From Human Sources
Anesthesiology (AN) · Part 868 Subpart D · § 868.3721
Identification
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. The AMStent® Tracheobronchial Covered Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms in adult patients.
Classification Rationale
Class II (special controls). The device is classified as Class II because the probable benefits outweigh the probable risks, and the risks can be mitigated using general controls and the identified special controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| SDB | Tracheal Prosthesis With Cover Material Derived From Human Sources | 2 | 1 | Implant |
Special Controls
SDB — Tracheal Prosthesis With Cover Material Derived From Human Sources
In combination with the general controls of the FD&C Act. the tracheal prosthesis with cover material derived from human sourcesis subject to the following special controls:
De Novo Order DEN230087
