BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P840068 · Supplement: S025 · Decision Nov 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    DELTA PACEMAKER SYSTEM
    PMA Number
    P840068
    Supplement Number
    S025
    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
    November 20, 1995
    Date Received
    April 6, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ALTERNATE MANUFACTURING SITE FOR ASSEMBLY OF THE EXTERNAL PRODUCTS (PROGRAMMERS, SOFTWARE MODULES/DISKS, EXTERNAL CARDIOVERTER DEFIBRILLATORS, AND RELATED ACCESSORIES) WHICH ARE USED WITH CPI PACEMAKER AND AICD SYSTEMS. THE PROPOSED ALTERNATE MANUFACTURING SITE (CARDIGAN FACILITY) IS LOCATED AT THE FOLLOWING ADDRESS:CPI CARDIGAN FACILITY, 599 CARDIGAN ROAD, SHOREVIEW, MINNESOTA 55126

    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)