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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)
2018 2019 2020 2021 2022 2023
7 2 1 2 0 0

MDR Year MDR Reports MDR Events
2018 8 8
2019 11 11
2020 4 4
2021 8 8
2022 11 11
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 21 21
Incorrect Measurement 12 12
High Test Results 11 11
Incorrect, Inadequate or Imprecise Result or Readings 3 3
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 20 20
No Clinical Signs, Symptoms or Conditions 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Consequences Or Impact To Patient 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Tosoh Bioscience Inc II Jun-05-2018
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