BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Renal

    PMA: P110001 · Supplement: S003 · Decision Jun 26, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Stent, Renal
    Trade Name
    RX HECULINK ELITE RENAL STENT SYSTEM
    PMA Number
    P110001
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    NIN
    Generic Name
    STENT, RENAL
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 26, 2012
    Date Received
    April 27, 2012
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol - OSB
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR POST-APPROVAL STUDY PROTOCOL.

    Classifications

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

    Product Code Device Name
    NIN Stent, Renal