BEUDAMED
    Product Code: PAT

    Bladder System

    Unknown

    The Bladder System is an implantable device intended for patients with complete spinal cord lesions (ASIA Classification) who have intact parasympathetic innervation of the bladder and are skeletally mature and neurologically stable. It is designed to provide urination on demand and to reduce post-void residual volumes of urine. The device carries a class of "f," indicating a special or biological regulatory pathway, with no regulation number or standard medical specialty assigned; it was reviewed by the Genitourinary panel. It is flagged as an implant but is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PAT
    Medical Specialty
    Unknown
    Review Panel
    GU
    Submission Type
    6

    Device Characteristics

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

    Definition

    for the treatment of patients who have complete spinal cord lesions (ASIA Classification) with intact parasympathetic innervation of the bladder and are skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void residual volumes of urine.