BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P980035 · Supplement: S233 · Decision Jul 28, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    ADAPTA, RELIA, SENSIA, & VERSA
    PMA Number
    P980035
    Supplement Number
    S233
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 28, 2011
    Date Received
    June 29, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    FIVE CHANGES TO GEN2 HYBRID TESTER FINAL TEST SOLUTION: 1) UPDATE TO THE FORCE MEASURE_NGT2 MODULE; 2) UPDATE THE PULSE AMPLITUDE AND PULSE WIDTH TEST , PULSE AMPLITUDE 7500 MV AND AMPLITUDE 7500 MV TEST SEQUENCES; 3) WIDEN THE TOLERANCE OF THE STABILITY CHECK CRITERIA FOR THE PULSE AMPLITUDE AND PULSE WIDTH TEST ;4) UPDATE THE CONFIGURATION SETTINGS FOR THE PULSE AMPLITUDE 7500 MV AND UNIPOLAR BIPOLAR SWITCH TEST AND THE INTER-CHAMBER CROSSTALK TEST; AND 5) UPDATE THE ELECTRICALLY ERASABLE PROGRAMMABLE READ ONLY MEMORY (EEPROM) CYCLIC REDUNDANCY CHECK (CRC).

    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