BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P210014 · Supplement: S002 · Decision Apr 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    Svelte SLENDER® Sirolimus-Eluting Coronary Stent Integrated Delivery System (SLENDER IDS®), Svelte DIRECT Sirolimus-Elut
    PMA Number
    P210014
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    NIQ
    Generic Name
    Coronary drug-eluting stent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 6, 2023
    Date Received
    March 14, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval to terminate of both PAS clinical studies, PAS001 continued follow-up of OPTIMIZE Clinical Study and PAS002 DIRECT IV Study

    Classifications

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

    Product Code Device Name
    NIQ Coronary Drug-Eluting Stent