BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P880086 · Supplement: S093 · Decision Mar 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A
    PMA Number
    P880086
    Supplement Number
    S093
    Device Class
    FDA Class 3
    Product Code
    DXY
    Generic Name
    implantable pacemaker Pulse-generator
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 20, 2003
    Date Received
    March 3, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A. THESE DEVICES ARE INDICATED AS FOLLOWS: IMPLANTATION OF IDENTITY ADX MODELS5386 AND 5380 PULSE GENERATORS IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: SYNCOPE, PRESYNCOPE, FATIGUE, DISORIENTATION, OR ANY COMBINATION OF THOSE SYMPTOMS. DUAL-CHAMBER PACING IS INDICATED FOR THOSE PATIENTS EXHIBITING: SICK SINUS SYNDROME, CHRONIC SYMPTOMATIC SECOND- AND THIRD-DEGREE AV BLOCK, RECURRENT ADAMS-STOKES SYNDROME, AND SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT. ATRIAL PACING IS INDICATED FOR PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV AND INTRAVENTRICULAR CONDUCTION SYSTEMS. VENTRICULAR PACING IS INDICATED FOR PATIENTS WITH SIGNIFICANT BRADYCARDIA AND: NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF A-V BLOCK OR SINUS ARREST, CHRONIC ATRIAL FIBRILLATION AND SEVERE PHYSICAL DISABILITY. AF SUPPRESSION IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION EPISODES IN PATIENTS WITH ONE OR MORE OF THE ABOVE PACING INDICATIONS.

    Classifications

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

    Product Code Device Name
    DXY Implantable Pacemaker Pulse-Generator