BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated External Defibrillators (Non-Wearable)

    PMA: P200004 · Decision Sep 26, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66

    Basic Information

    Device Name
    Automated External Defibrillators (Non-Wearable)
    Trade Name
    ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters
    PMA Number
    P200004
    Device Class
    FDA Class 3
    Product Code
    MKJ
    Generic Name
    Automated external defibrillators (non-wearable)
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 26, 2021
    Date Received
    January 31, 2020
    Expedited Review
    N
    Docket Number
    21M-1046

    Advisory Committee Statement

    Approval for an Adult/Child 2001(radiotransparent), 2516(radiotranslucent):The ConMed PadPro radiotransparent and radiotranslucent external multifunction electrodes (MFEs). The device is indicated for use by trained medical professionals in medical facilities or medical transport environments to deliver energy for defibrillation, cardioversion, external pacing, and ECG monitoring applications. The MFE is a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. This device is intended for use on defibrillators whose output is classified as low power (up to 360 Joule maximum).AED Use: When used in AED mode i.e. for victims of cardiac arrest where there is apparent lack of circulation as indicated by unconsciousness, absence of breathing, and absence of pulse, the electrode is intended for use on patients weighing 25 kg (55 lbs.) or more. PadPro MFEs are not intended to be used for public access pediatric AED defibrillation purposes.Manual Use:When used in manual mode, i.e. under direction of a qualified health care professional, the electrode is intended for use on adult / child patients weighing 10 kg (22 lbs.) or more.Adult/Child Model 2502 (Sterile):The ConMed PadPro radiotransparent external multifunction electrodes (MFEs) are indicated for use by trained medical professionals in medical facilities or medical transport environments to deliver energy for defibrillation, cardioversion, external pacing, and ECG monitoring applications. The MFE is a sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. The device is intended for use on defibrillators whose output is classified as low power (up to 360 Joule maximum).AED Use:See Adult/Child 2001, 2516Manual Use:See Adult/Child 2001, 2516Infant Model 2603 and Mini-Infant Model 2602:The ConMed PadPro radiotranslucent external multifunction electrodes (MFEs) are indicated for use by trained medical professionals in medical facilities to deliver energy for defibrillation, cardioversion, external pacing, and ECG monitoring applications. The MFE is a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient’s skin. Not for use in AED mode.Manual Use:When used in the manual mode, i.e. under direction of a qualified health care professional, the electrode is intended for use on infant patients (3-10kg) and mini-infant patients (<3kg). Follow American Heart Association (AHA) guidelines for administration of energy levels, which recommends a first dose of 2J/kg, and subsequent doses of 4J/kg. During Refractory ventricular fibrillation, do not exceed a maximum energy level of 10J/kg.PadPro Adapters:The ConMed PadPro adapters are indicated for use by trained medical professionals in medical facilities or medical transport environments to adapt connection systems associated with a specific defibrillator/therapy cable to a different style connection system. The PadPro MFE adapters are intended for delivery of energy for defibrillation, cardioversion, external pacing, and ECG monitoring applications. The PadPro MFE adapter is a non-sterile, reusable device, providing conductive interface between the defibrillator and/or therapy cable and MFE electrode. This device is intended for use on defibrillators whose output is classified as low power (up to 360 Joule maximum).

    Classifications

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

    Product Code Device Name
    MKJ Automated External Defibrillators (Non-Wearable)