BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P910023 · Supplement: S185 · Decision Aug 19, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    CADENCE ICD SYSTEM
    PMA Number
    P910023
    Supplement Number
    S185
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 19, 2008
    Date Received
    August 11, 2008
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE QUICKSTART GUIDE (LABELING FOR THE MERLIN@HOME DM EX1150 TRANSMITTER.)

    Classifications

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

    Product Code Device Name
    NVZ Pulse Generator, Permanent, Implantable