(142 days)
The Atrium Advanta TM PTFE Facial Implant is intended for use in Facial Plastic and Reconstructive Surgery.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Atrium Advanta™ PTFE Facial Implant. It does not contain any information regarding acceptance criteria, device performance studies, or the methodologies used to establish ground truth or conduct clinical trials.
This document is primarily concerned with the regulatory clearance of a medical device based on its substantial equivalence to a legally marketed predicate device. It describes the regulatory classification, general controls provisions, and contact information for further inquiries, but does not detail the technical or performance aspects of the device that would be assessed in a clinical study.
Therefore, I cannot provide the requested information based on the input text.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.