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510(k) Data Aggregation

    K Number
    K992991
    Device Name
    ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2000-01-27

    (142 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Atrium Advanta TM PTFE Facial Implant is intended for use in Facial Plastic and Reconstructive Surgery.

    Device Description

    Not Found

    AI/ML Overview

    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.

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