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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, tracheal, expandable, polymeric
Regulation Description Tracheal prosthesis.
Definition The device is intended to provide support to weakened or constricting airway walls and indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures, after all alternative therapies have been exhausted.
Product CodeNYT
Regulation Number 878.3720
Device Class 2


Premarket Reviews
ManufacturerDecision
RUSCH, INC.
  1

Device Problems
Migration of device or device component 7
Use of Device Issue 6
Positioning Issue 5
Other (for use when an appropriate device code cannot be identified) 4
No Known Device Problem 3
No code available 2
Implant, removal of 1
Folded 1
Implant breakage or physical damage 1
Buckled material 1
Difficult to advance 1
Dislodged or dislocated 1
Normal 1
Premature deployment 1
Device Difficult to Setup or Prepare 1
Component(s), broken 1
Difficult to deploy 1
Failure to deploy 1
Material fragmentation 1
Hole in material 1
Total Device Problems 41

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