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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tongue suspension system
Definition Intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with a suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.
Product CodeORY
Regulation Number 872.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
SIESTA MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
SIESTA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 2 2
2019 2 2
2020 2 2
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Positioning Problem 1 1
Fracture 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Apnea 5 5
Unspecified Infection 2 2
Pain 1 1
Patient Problem/Medical Problem 1 1

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