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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, tracheal, preformed/molded
Regulation Description Tracheal prosthesis.
Definition The device is intended to provide support to weakened or constricting airway walls.
Product CodeNWA
Regulation Number 878.3720
Device Class 2


Premarket Reviews
ManufacturerDecision
NEW COS INC. DBA VISIONAIR SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
NOVATECH SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2 4

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 2 4
Obstruction of Flow 1 3
Inadequacy of Device Shape and/or Size 1 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Airway Obstruction 1 3
Pneumonia 1 3
Pulmonary Dysfunction 1 1
Stenosis 1 3
Fungal Infection 1 3
Respiratory Failure 1 3

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