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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, catheter control, steerable
Product CodeDXX
Regulation Number 870.1290
Device Class 2


Premarket Reviews
ManufacturerDecision
CORINDUS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 9 9
2020 4 4
2021 5 5
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Component or Accessory Incompatibility 2 2
Electrical Shorting 2 2
Electrical /Electronic Property Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Break 2 2
Thermal Decomposition of Device 1 1
Mechanical Problem 1 1
Product Quality Problem 1 1
Human-Device Interface Problem 1 1
Inadequate User Interface 1 1
Material Deformation 1 1
Power Problem 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Activation Problem 1 1
Fail-Safe Did Not Operate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 9 9
No Clinical Signs, Symptoms or Conditions 3 3
No Consequences Or Impact To Patient 2 2
No Patient Involvement 1 1
Chest Pain 1 1
Vertigo 1 1
Vascular Dissection 1 1
Movement Disorder 1 1
Speech Disorder 1 1
Paresthesia 1 1
Insufficient Information 1 1

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