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

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    PMA: P060027 · Supplement: S062 · Decision Apr 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26

    Basic Information

    Device Name
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
    Trade Name
    PARADYM RF CRT-D
    PMA Number
    P060027
    Supplement Number
    S062
    Device Class
    FDA Class 3
    Product Code
    NIK
    Generic Name
    Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 16, 2014
    Date Received
    March 24, 2014
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES FOR THE DEVICES (PLATFORM ZL102):1) ADDED EQUIPMENT COOLER STACKER/DE-STACKER USED IN THE ELECTRONIC SMD ASSEMBLY LINE;2) LASER WELDING PROCESS REWORK FOR VISUAL DEFECT ON CASE; AND3. PARADYM RF (ZL102), IN SOURCING OF RF MODULE MANUFACTURING

    Classifications

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

    Product Code Device Name
    NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)