BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P910023 · Supplement: S115 · Decision Sep 18, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    HOUSECALL PLUS WITH TRANSMITTER SOFTWARE VERSION 3.0, RECEIVER SOFTWARE VERSION 3.0 AND TRANSMITTER HARDWARE VERSION H
    PMA Number
    P910023
    Supplement Number
    S115
    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
    September 18, 2006
    Date Received
    August 4, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MODIFICATIONS TO THE ST. JUDE MEDICAL HOUSECALL PLUS TO ADD SUPPORT FOR ATLAS II AND EPIC II ICD FAMILIES AND TO REMOVE THE SURFACE ECG FUNCTION.

    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