BEUDAMED
    Product Code: PAL 21 CFR 870.3925

    Pulmonic Replacement Heart Valve

    Cardiovascular

    The Pulmonic Replacement Heart Valve is a cardiovascular implant used for the open surgical replacement of a malfunctioning pulmonic heart valve. Its device class is listed as "f" (indicating it is classified under a specific special framework or preamendment status) with the applicable regulation number 870.3925 under the Cardiovascular medical specialty. The product code is PAL, and it carries both an implant flag and a life-sustaining/support flag, reflecting its critical role in maintaining cardiac function.

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    510(k)s
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    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    PAL
    Regulation Number
    870.3925
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    6

    Device Characteristics

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

    Definition

    For open surgical replacement of malfunctioning pulmonic heart valve.