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510(k) Data Aggregation

    K Number
    K040417
    Device Name
    PILLAR PALATAL IMPLANT SYSTEM
    Date Cleared
    2004-07-28

    (161 days)

    Product Code
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESTORE MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pillar™ Palatal Implant System is intended for the reduction of the incidence of airway obstructions in patients suffering from mild to moderate OSA (Obstructive Sleep Apnea).
    Device Description
    The Pillar™ Palatal Implant System (“System”) is intended as a treatment option for snoring and obstructive sleep apnea. The System consists of an implant and a delivery tool. The implants are designed to stiffen the tissue of the soft palate reducing the dynamic flutter which causes snoring. Additionally, the implants reduce the incidence of airway obstruction caused by the soft palate. The implant is a cylindrical shaped segment of braided polyester filaments. The delivery tool is comprised of a handle and needle assembly that allows for positioning and placement of the implant submucosally in the soft palate. The implant is designed to be permanent while the delivery tool is disposable.
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