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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device intravascular radiation delivery system
Product CodeMOU
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
1 0 1 0 0 0

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

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Positioning Failure 1 1
Entrapment of Device 1 1
Failure to Advance 1 1
Detachment of Device or Device Component 1 1
Material Integrity Problem 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1

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