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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 total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Product CodeMTF
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
8 14 6 5 10 3

MDR Year MDR Reports MDR Events
2019 21 21
2020 14 14
2021 46 46
2022 45 45
2023 30 30
2024 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 96 96
Low Test Results 64 64
Non Reproducible Results 18 18
Incorrect Measurement 15 15
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Output Problem 2 2
No Apparent Adverse Event 2 2
Insufficient Information 2 2
Leak/Splash 1 1
No Device Output 1 1
Unable to Obtain Readings 1 1
High Readings 1 1
Low Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 144 144
No Consequences Or Impact To Patient 23 23
No Known Impact Or Consequence To Patient 13 13
Osteopenia/ Osteoporosis 9 9
Insufficient Information 4 4
No Code Available 1 1

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