BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    PMA: P070008 · Supplement: S094 · Decision Feb 12, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25

    Basic Information

    Device Name
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
    Trade Name
    Evia HF/ HF-T; Entovis HF/ HF-T; Edora 8 HF-T; Enitra 8 HF-T; Enticos 8 HF-T; Evity 8 HF-T; Etrinsa 8 HF T; Epyra 8 HF-T
    PMA Number
    P070008
    Supplement Number
    S094
    Device Class
    FDA Class 3
    Product Code
    NKE
    Generic Name
    Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 12, 2019
    Date Received
    June 14, 2018
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the implementation of new biological indicators and reduction of incubation time for the bioindicators for the sterilization process, the use of sterilization process P02 as an alternate sterilization process for cables and adaptors, and parametric release for the sterilization processes.

    Classifications

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

    Product Code Device Name
    NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)