BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P950037 · Supplement: S059 · Decision Nov 4, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    ACTROS, AXIOS, BA03, CYLOS, DROMOS, KAIROS, PHILOS, PHILOS II, AND PROTOS FAMILIES OF PULSE GENERATORS
    PMA Number
    P950037
    Supplement Number
    S059
    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 4, 2008
    Date Received
    May 14, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF MODELS 500/540 TO THE LUMAX FAMILY OF ICD/CRT-DSAND ICS 3000 PROGRAMMER. THESE MODELS WOULD CONTAIN:¿ A THIRD PROGRAMMABLE CARDIOVERSION / DEFIBRILLATION SHOCK PATHWAY TO OFFER MOREPROGRAMMING OPTIONS¿ AUTOMATIC THRESHOLD MEASUREMENT (ATM) FEATURE ¿ ELECTRONIC MODULE (HARDWARE) UPDATES TO SUPPORT THE THIRD PROGRAMMABLE SHOCK PATH¿ MODIFICATIONS TO THE LITRONIK BATTERIES TO INCREASE CAPACITY¿ NEW STANDARD VALUE OF THE PROGRAMMABLE PACING PULSE WIDTH¿ UPDATED RAM FIRMWARE TO SUPPORT NEW FEATURES

    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