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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 test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Product CodeMTG
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
7 9 13 7 4 7

MDR Year MDR Reports MDR Events
2018 12 12
2019 13 13
2020 6 6
2021 9 9
2022 4 4
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 22 22
Incorrect Measurement 8 8
Low Test Results 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Non Reproducible Results 3 3
No Apparent Adverse Event 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 19 19
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 14 14

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