BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P960043 · Supplement: S031 · Decision Nov 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    CLOSER / CLOSER S 6 FRENCH SMC SYSTEMS
    PMA Number
    P960043
    Supplement Number
    S031
    Device Class
    FDA Class 3
    Product Code
    MGB
    Generic Name
    Device, hemostasis, vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 20, 2001
    Date Received
    January 29, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE CLOSER 6 FR. SYSTEMS DURING INTERVENTIONAL CATHETERIZATION (EXPANDED INDICATIONS FOR USE) REQUIRING 7 TO 8 FR. SHEATHS. THE CLOSER AND THE CLOSER S 6 FR. SMC SYSTEMS ARE MODIFIED, AS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5 TO 8 FR. SHEATHS. THE CLOSER AND THE CLOSER S 6 FR. SMC SYSTEMS REDUCED THE TIMES TO HEMOSTASIS, AMBULATION (10 FEET) AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS (REFER TO PRECAUTIONS, SPECIAL PATIENT POPULATIONS).

    Classifications

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

    Product Code Device Name
    MGB Device, Hemostasis, Vascular