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Applicant Name (Manufacturer) :
**The Center for Craniofacial **& Dental Sleep Medicine
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Meridian PM is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Device Description
The Meridian PM is a single device consisting of two parts and upper appliance and lower appliance it is collectively known as the Meridian PM : The Meridian PM treats snoring and Obstructive Sleep Apnea (OSA).
The Meridian PM device is used in a patient treatment model for specific diagnosis of simple snoring, and/or Obstructive Sleep Apnea (OSA).
The upper and lower appliances help to reposition the lower jaw such that it is moved to a forward position during sleep.
The Meridian PM system is used for treating snoring and obstructive sleep apnea and consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable vertical wings, or by the industry standard "Herbst mechanism" which is a rod and tube type assembly that orientates the jaws in a predetermined relationship. These device(s) function as a mandibular repositioning or mandibular advancment device (MAD) as Meridian PM acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep, decreasing symptoms of OSA. The devices will be custom made for each patient and allow the dentist or physician to control the degree of mandibular advancement at the time of device(s) will be sold by prescription only.
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