BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

    PMA: P000057 · Supplement: S011 · Decision Mar 5, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis
    Trade Name
    Ascension MCP
    PMA Number
    P000057
    Supplement Number
    S011
    Device Class
    FDA Class 3
    Product Code
    NEG
    Generic Name
    Finger semi-constrained pyrolytic carbon uncemented prosthesis
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 5, 2019
    Date Received
    October 10, 2018
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    Approval for labeling changes to the package insert, surgical technique, patient information brochure, and post-operative therapy brochure.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NEG Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis