BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P010012 · Supplement: S151 · Decision Aug 24, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    CONTAK RENEW 3 RF
    PMA Number
    P010012
    Supplement Number
    S151
    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
    August 24, 2007
    Date Received
    June 18, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES TO THE CONTAK RENEWAL 3 RF MODELS H210, H215, H217, AND H219: 1) DIGITAL IC PAD CHANGE TO ADDRESS PREMATURE BATTERY DEPLETION. 2) HYBRID MOTHERBOARD DFN TRACE RE-ROUTING FROM OUTSIDE LAYER ?4? TO AN INSIDE LAYER ?3? TO REDUCE ELECTRICAL FIELD INTENSITY AND POSSIBLE ARCING. 3) TRIM TARGET ADJUSTMENT.

    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)