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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 device, angioplasty, laser, coronary
Product CodeLPC
Device Class 3

Premarket Approvals (PMA)
2014 2015 2016 2017 2018 2019
7 7 7 10 8 2

Device Problems
Adverse Event Without Identified Device or Use Problem 10
Detachment of Device or device Component 7
Material Deformation 5
Material Split, Cut or Torn 3
Material Protrusion / Extrusion 2
Device Displays Incorrect Message 2
Material Fragmentation 1
Material Frayed 1
Solder Joint Fracture 1
Pressure Problem 1
Incorrect Or Inadequate Test Results 1
Use of Device Problem 1
Detachment Of Device Component 1
Insufficient Information 1
Total Device Problems 37

Recalls
Manufacturer Recall Class Date Posted
1 Spectranetics Corporation II Nov-28-2016

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