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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prostate-specific antigen (psa) for management of prostate cancers
Product CodeLTJ
Regulation Number 866.6010
Device Class 2

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
2 1 2 0 2 1

MDR Year MDR Reports MDR Events
2019 11 11
2020 4 4
2021 8 8
2022 11 11
2023 17 17
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 19 19
Low Test Results 18 18
High Test Results 15 15
Non Reproducible Results 5 5
Incorrect, Inadequate or Imprecise Result or Readings 3 3
No Apparent Adverse Event 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 35 35
No Known Impact Or Consequence To Patient 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Consequences Or Impact To Patient 3 3

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