BEUDAMED
    Product Code: PSR FDA class 3

    Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

    Unknown

    The Implanted Phrenic Nerve Stimulator for Central Sleep Apnea is an implantable device that stimulates the phrenic nerve to produce diaphragm movement during sleep, thereby treating central sleep apnea by restoring respiratory drive without the need for continuous positive airway pressure. It is classified as FDA Class 3, requiring Premarket Approval (PMA) due to the high risk of implanted neurostimulators affecting breathing, and is reviewed by the Anesthesiology panel. Product code PSR; flagged as an implant; no regulation number assigned; not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PSR
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    AN
    Submission Type
    2

    Device Characteristics

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

    Definition

    The device is intended to stimulate the phrenic nerve to produce diaphragm movement during sleep.

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.