BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P010012 · Supplement: S160 · Decision May 16, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    ACUITY SPIRAL HEART FAILURE LEAD MODELS, 4591, 4592 AND 4593
    PMA Number
    P010012
    Supplement Number
    S160
    Device Class
    FDA Class 3
    Product Code
    LWP
    Generic Name
    Implantable pulse generator, pacemaker (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 16, 2008
    Date Received
    October 9, 2007
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ACUITY SPIRAL LEAD MODEL 4591, 4592, AND 4593. THE DEVICE IS INDICATED FOR CHRONIC, LEFT-VENTRICULAR PACING AND SENSING VIA THE CORONARY VEINS WHEN USED IN CONJUNCTION WITH A COMPATIBLE PULSE GENERATOR.

    Classifications

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

    Product Code Device Name
    LWP Implantable Pulse Generator, Pacemaker (Non-Crt)