BEUDAMED
    Product Code: MAF FDA class 3

    Stent, Coronary

    Unknown

    The Coronary Stent (product code MAF), formerly classified as a Cardiovascular Stent, is a metal scaffold delivered via catheter and deployed within a coronary artery or saphenous vein graft to maintain the lumen patency following angioplasty, preventing restenosis after percutaneous coronary intervention. It is classified as a Class 3 device requiring Premarket Approval (PMA) and is flagged as an implant, reflecting its permanent placement within the coronary vasculature. The device has no formal regulation number or medical specialty designation and is reviewed under the Cardiovascular (CV) panel. It is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    21
    Registration Numbers
    21
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    MAF
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    CV
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    The formerly known device, Cardiovascular Stent, coded as "MAF" has been modified and is currently known and classified as a "Coronary Stent". This device is a metal scaffold placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.

    FEI Numbers

    This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.