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

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    PMA: P010015 · Supplement: S189 · Decision Mar 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
    Trade Name
    CONSULTA CRT-P, SYNCRA CRT-P
    PMA Number
    P010015
    Supplement Number
    S189
    Device Class
    FDA Class 3
    Product Code
    OJX
    Generic Name
    Drug eluting permanent left ventricular (lv) pacemaker electrode
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 20, 2013
    Date Received
    February 21, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    IC MANUFACTURE TEST CHANGES FOR THE ADVISA DR IPG A4DR01, ADVISA MRI IPG A2DR01,CONSULTA CRT-P C4TR01, SYNCRA CRT-P C2TR01, CONCERTO II CRT-D D274TRK, CONSULTA DF4 ICD D204TRM, CONSULTA ICD D224TRK,MAXIMO II CRT-D D264TRM, D284TRK, PROTECTA CRT-D D334TRG, D334TRM, PROTECTA XT CRT-D D314TRG, D314TRM, MAXIMO II ICD D264DRM, D264VRM, D284DRG, D284VRC, PROTECTA ICDD334DRG, D334DRM, D334VRG, D334VRM, PROTECTA XT ICD D314DRG, D314DRM, D314VRG, D314VRM, SECURA ICD D204DRM, D204VRM, D224DRG, D224VRC, VIRTUOSO II DR/VR ICD D274DRG AND D274VRC.

    Classifications

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

    Product Code Device Name
    OJX Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode