BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P010012 · Supplement: S260 · Decision Aug 5, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    ACUITY SPIRAL LEAD FAMILY
    PMA Number
    P010012
    Supplement Number
    S260
    Device Class
    FDA Class 3
    Product Code
    LWP
    Generic Name
    Implantable pulse generator, pacemaker (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 5, 2011
    Date Received
    November 26, 2010
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES: 1) ADD AN ALTERNATE DEXAMETHASONE ACETATE SUPPLIER; 2) UPDATE TO DXA MIXING PROCESS PARAMETERS TO ENHANCE PROCESS CAPABILITY; 3) ALTERNATE ANALYTICAL METHOD TO TEST FOR DOSAGE AND PRODUCT DEGRADATION; 4) MODIFICATION OF THE ANALYTICAL METHODS TO REMOVE IMPURITY PEAKS OBSERVED; AND 5) ADD IN PROCESS VERIFICATION FOR MIX HOMOGENEITY.

    Classifications

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

    Product Code Device Name
    LWP Implantable Pulse Generator, Pacemaker (Non-Crt)