BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Coronary

    PMA: P000011 · Supplement: S003 · Decision Dec 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stent, Coronary
    Trade Name
    PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIOH SV STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYST SV OTW), AND PC C)
    PMA Number
    P000011
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    MAF
    Generic Name
    STENT, CORONARY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 21, 2001
    Date Received
    June 28, 2001
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) THE BIODIVYSIO(TM) SV OTW IN 10 MM, 15 MM AND 18 MM STENT LENGTHS AND 2.0 MM AND 2.5 MM DIAMETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIODIVYSIO(TM) SV OTW AND IS INDICATED FOR "IMPROVING CORONARY LUMINAL DIAMETER IN SUBJECTS EXPERIENCING ABRUPT CLOSURE OR THREATENED ABRUPT VESSEL CLOSURE FOLLOWING PERCUTANEOUS REVASCULARIZATION OF DE NOVO OR NON IN-STENT RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH OF LESION AND/OR DISSECTION <=25 MM) WITH A REFERENCE VESSEL DIAMETER RANGING FROM >=2.0 MM TO <=3.0 MM BY VISUAL ESTIMATE. LONG-TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS IMPLANT IS UNKNOWN AT PRESENT." 2) THE BIODIVYSIO(TM) AS OTW IN 11 MM AND 15 MM STENT LENGTHS AND 3.0 MM, 3.5 MM AND 4.0 MM DIAMETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIODIVYSIO(TM) AS OTW AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: A)SUBJECTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <=25 MM) WITH A REFERENCE VESSEL DIAMETER RANGING FROM >=3.0 MM TO 4.0 MM; B)SUBJECTS EXPERIENCING ABURPT CLOSURE OR THREATENED ABRUPT VESSEL CLOSURE FOLLOWING PERCUTANEOUS REVASCULARIZATION OF DE NOVO OR NON IN-STENT RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH OF LESION AND/OR DISSECTION <=25 MM) WITH REFERENCE VESSEL DIAMETER RANGING FROM >=3.0 MM TO <=4.0 MM BY VISUAL ESTIMATION. LONG TERM OUTCOME (BEYOND 6 MONTHS) FOR THESE PERMANENT IMPLANTS ARE UNKNOWN AT PRESENT.

    Classifications

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

    Product Code Device Name
    MAF Stent, Coronary