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


Premarket Reviews
ManufacturerDecision
NANOENTEK USA INC
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
9 7 2 1 2 0

MDR Year MDR Reports MDR Events
2017 13 13
2018 8 8
2019 11 11
2020 4 4
2021 8 8
2022 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 22 22
High Test Results 17 17
Incorrect Measurement 8 8
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Defective Device 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 29 29
No Clinical Signs, Symptoms or Conditions 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Consequences Or Impact To Patient 4 4
No Code Available 2 2
Tissue Damage 1 1

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