BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

    PMA: P000057 · Supplement: S009 · Decision Aug 4, 2017
    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
    S009
    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
    August 4, 2017
    Date Received
    June 21, 2016
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

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

    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