BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P910023 · Supplement: S201 · Decision Apr 8, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    CADENCE FAMILY OF ICDS
    PMA Number
    P910023
    Supplement Number
    S201
    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
    April 8, 2009
    Date Received
    February 10, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CURRENT/CURRENT+ AND PROMOTE/PROMOTE+ DEVICES INCLUDING CURRENT- DR CD2211-36Q, CURRENT+ VR CD1211-36Q, PROMOTE + CD3211-36Q, CURRENT VR CD1207-36Q, CURRENT DR 2207-36Q, AND PROMOTE CD3207-36Q. ADDITIONALLY, YOUREQUESTED APPROVAL TO INCLUDE THE DEVICES WITHIN AN ONGOING POST APPROVAL STUDY, PENDING FINAL APPROVAL BY THE OFFICE OF SURVEILLANCE AND BIOMETRICS. THAT POST-APPROVAL STUDY IS BEING CONDUCTED AS A CONDITION OF APPROVAL FOR P950022/S042, P030054/S067, AND P910023/S154.

    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