BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

    PMA: P000057 · Supplement: S014 · Decision Aug 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis
    Trade Name
    ASCENSION MCP
    PMA Number
    P000057
    Supplement Number
    S014
    Device Class
    FDA Class 3
    Product Code
    NEG
    Generic Name
    Finger semi-constrained pyrolytic carbon uncemented prosthesis
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 5, 2025
    Date Received
    July 9, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval to introduce new quarterly product endotoxin testing.

    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