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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device system, test, her-2/neu, ihc
Product CodeMVC
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
7 6 1 3 2 2

MDR Year MDR Reports MDR Events
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 1 1
Unclear Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Breast Cancer 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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