BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Pulse Generator, External Pacemaker, Dual Chamber

    PMA: P950037 · Supplement: S084 · Decision May 8, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Pulse Generator, External Pacemaker, Dual Chamber
    Trade Name
    REOCOR S / D FAMILY OF EXTERNAL PACEMAKERS
    PMA Number
    P950037
    Supplement Number
    S084
    Device Class
    FDA Class 2
    Product Code
    OVJ
    Generic Name
    Pulse Generator, External Pacemaker, Dual Chamber
    Regulation Number
    870.3600
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 8, 2012
    Date Received
    July 14, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR TWO NEW FAMILIES OF TEMPORARY EXTERNAL PACEMAKER PULSE GENERATORS. NEW FEATURES INCLUDE: 1) REDEL PACING WIRE CONNECTION ADAPTERS; 2) TRIGGER MODES VT AND SST; 3) SENSITIVITY SETTINGS UP TO 20 MV FOR THE REOCOR S MODEL; AND 3) PROGRAMMABLE AV DELAY UP TO 400 MS. THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES REOCOR S AND REOCOR D AND IS INDICATED FOR: TEMPORARY PACING; TEMPORARY TREATMENT OF ARRHYTHMIAS AND HEART BLOCK; SYMPTOMATIC SINUS BRADYCARDIA; PRE-, INTRA-, AND POSTOPERATIVE TEMPORARY STIMULATION OF PATIENTS UNDERGOING CARDIAC SURGERY; TERMINATION OF SUPRAVENTRICULAR TACHYARRHYTHMIAS; PROPHYLACTIC PACING FOR PREVENTION OF ARRHYTHMIAS; EMERGENCY PACING; AND CHECKING PACING THRESHOLDS.

    Classifications

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

    Product Code Device Name
    OVJ Pulse Generator, External Pacemaker, Dual Chamber