BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P950037 · Supplement: S116 · Decision Mar 18, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    VARIOUS MODELS OF IPG'S: ACTROS, AXIOS, CYLOS, DROMOS, KAIROS, PHILOS/II, PROTOS, ETC.
    PMA Number
    P950037
    Supplement Number
    S116
    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
    March 18, 2013
    Date Received
    December 18, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ILESTO 7/5 VR-T ICD, ILESTO 7/5 VR-T DX ICD, ILESTO 7/5 DR-T ICD, ILESTO 7/5 HFT CRT-D; IFORIA 7/5 VR-T ICD, IFORIA 7/5 VR-T DX ICD, IFORIA 7/5 DR-T ICD, IFORIA 7/5 HF-T CRT-D; AND THE PSW 1205.U.

    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