BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Carotid

    PMA: P040012 · Supplement: S003 · Decision Mar 16, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Stent, Carotid
    Trade Name
    ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM
    PMA Number
    P040012
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    NIM
    Generic Name
    Stent, carotid
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 16, 2006
    Date Received
    December 22, 2005
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF MODIFICATIONS TO THE PROTOCOL FOR THE ARCHER LONG TERM FOLLOW-UP (LTFU) TRIAL. THE REVISED PROTOCOL INCLUDES MEASURES DESIGNED TO ASSIST IN THE RECRUITMENT AND EVALUATION OF PATIENTS, AND COMPLIES WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE AUGUST 30, 2004 APPROVAL ORDER FOR P040012.

    Classifications

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

    Product Code Device Name
    NIM Stent, Carotid