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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device prosthesis, tracheal, expandable, polymeric
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

MDR Year MDR Reports MDR Events
2016 2 2
2017 3 3
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Deformation 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Partial Blockage 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 6 6

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