BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P980035 · Supplement: S097 · Decision Nov 26, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    MEDTRONIC RELIA IMPLANTABLE PULSE GENERATOR AND MODEL SW010APPLICATION SOFTWARE
    PMA Number
    P980035
    Supplement Number
    S097
    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
    November 26, 2008
    Date Received
    June 2, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MEDTRONIC RELIA SERIES OF PULSE GENERATORS WHICH ARE RATE RESPONSIVE, MULTI-PROGRAMMABLE, SINGLE AND DUAL CHAMBER DEVICES (MODELS REDR01, RED01, REVDD01, RESR01, RES01) AND THE ASSOCIATED SW010 APPLICATIONS SOFTWARE (VERSION 1.0).

    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