BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Bulking, Injectable For Gastro-Urology Use

    PMA: P980053 · Supplement: S006 · Decision Aug 26, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Agent, Bulking, Injectable For Gastro-Urology Use
    Trade Name
    DURASPHERE EXP
    PMA Number
    P980053
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    LNM
    Generic Name
    AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 26, 2003
    Date Received
    March 7, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFIED BEAD SPECIFICATION (90-212 UM) FOR THE PYROLYTIC CARBON COATED ZIRCONIUM OXIDE AND GRAPHITE BEADS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DURASPHERE EXP AND IS INDICATED FOR USE IN THE TREATMENT OF ADULT WOMEN WITH STRESS URINARY INCONTINENCE (SUI) DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD).

    Classifications

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

    Product Code Device Name
    LNM Agent, Bulking, Injectable For Gastro-Urology Use