21 CFR 878.3720 — Prosthesis, Tracheal, Expandable
General, Plastic Surgery (SU) · Part 878 Subpart D—Prosthetic Devices · § 878.3720
Identification
The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.
Classification Rationale
Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JCT | Prosthesis, Tracheal, Expandable | 2 | 45 | Implant, Life-Sustaining |
| NWA | Prosthesis, Tracheal, Preformed/Molded | 2 | 6 | Implant |
| NYT | Prosthesis, Tracheal, Expandable, Polymeric | 2 | 3 | Implant |
Special Controls
JCT — Prosthesis, Tracheal, Expandable
The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”
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