BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    PMA: P960004 · Supplement: S059 · Decision Oct 8, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26

    Basic Information

    Device Name
    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
    Trade Name
    FINELINE II STEROX AND STEROX EZ ENDOCARDIAL PACING LEAD
    PMA Number
    P960004
    Supplement Number
    S059
    Device Class
    FDA Class 3
    Product Code
    NVN
    Generic Name
    Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 8, 2015
    Date Received
    March 27, 2013
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING:1) A STERILIZATION PROCESS CHANGE FROM OXYFUME TO 100% ETHYLENE OXIDE;2) DRUG SPECIFICATION CHANGES; 3) LABELING CHANGES; 4) TO FINISH REMAINING 3 MONTHS OF LOT RELEASE STUDY FOR PASSIVE FIXATION LEADS AS NON-CLINICAL POST APPROVAL STUDY;4) MANUFACTURING CHANGES TO REDUCE ELUTION VARIATION;5) TO UPDATE ACTIVE FIXATION BATCH RELEASE STUDY PROTOCOL TO IMPLEMENT NEW MANUFACTURING CHANGES; AND6) TO COMPLETE 12 MONTH LOT RELEASE STUDY AS NON-CLINICAL POST APPROVAL STUDY.

    Classifications

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

    Product Code Device Name
    NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes