SDB · Tracheal Prosthesis With Cover Material Derived From Human Sources
Anesthesiology · 21 CFR 868.3721 · Class 2
Overview
| Product Code | SDB |
|---|---|
| Device Name | Tracheal Prosthesis With Cover Material Derived From Human Sources |
| Regulation | 21 CFR 868.3721 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Implant | Yes |
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.
Special Controls
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:
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN230087 | AMStent® Tracheobronchial Covered Stent System | Peytant Solutions, Inc. | Oct 16, 2024 | DENG |
Top Applicants
- Peytant Solutions, Inc. — 1 clearance
