BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P980035 · Supplement: S277 · Decision Jan 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR
    PMA Number
    P980035
    Supplement Number
    S277
    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
    January 15, 2013
    Date Received
    June 29, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF AN MR-CONDITIONAL SYSTEM PERMITTING IMPLANTED PATIENTS TO UNDERGO MRI SCANS PROVIDED SPECIFIED CONDITIONS ARE MET. THE DEVICES, AS MODIFIED, MAKE UP THE ADVISA DR MRI SURESCAN SYSTEM AND WILL BE MARKETED UNDER THE TRADE NAMES ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR WITH SOFTWARE MODEL 9995, CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL 2020A AND DDMA MODEL 2491. THE ADVISA DR MRI SURESCAN SYSTEM IS INDICATED FOR THE FOLLOWING: 1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN ACTIVITY; AND2) ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING INCLUDE:A) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND-OR THIRD-DEGREE A VBLOCK; B) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK; C) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED A V CONDUCTION DISORDERS D) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS; AND E) VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES. THE DEVICE IS ALSO INDICATED FOR DUAL CHAMBER AND ATRIAL TRACKING MODES IN PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY. DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY, WHICH INCLUDE:1) VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TOCARDIAC OUTPUT; AND 2) VVI INTOLERANCE (FOR EXAMPLE, PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHMANTITACHYCARDIA PACING (A TP) IS INDICATED FOR TERMINATION OF ATRIALTACHYARRHYTHMIAS IN BRADYCARDIA 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
    NVZ Pulse Generator, Permanent, Implantable