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510(k) Data Aggregation
K Number
K040417Device Name
PILLAR PALATAL IMPLANT SYSTEM
Manufacturer
Date Cleared
2004-07-28
(161 days)
Product Code
Regulation Number
872.5570Why 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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