BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

    PMA: P000057 · Supplement: S010 · Decision Jun 29, 2018
    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
    S010
    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
    June 29, 2018
    Date Received
    October 3, 2017
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at Integra Life Sciences Corporation (Integra), 11101 Metric Boulevard, Austin, Texas.

    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