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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
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.
  SUBSTANTIALLY EQUIVALENT 1
NEW COS INC. DBA VISIONAIR SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2021 2 2

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Airway Obstruction 1 1
Pneumonia 1 1
Pulmonary Dysfunction 1 1
Stenosis 1 1
Fungal Infection 1 1
Respiratory Failure 1 1
No Known Impact Or Consequence To Patient 1 1

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