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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
Regulation Description Tumor-associated antigen immunological test system.
Product CodeLTJ
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
NANOENTEK USA INC
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
2 9 7 2 1 1

MDR Year MDR Reports MDR Events
2016 8 8
2017 13 13
2018 8 8
2019 11 11
2020 4 4
2021 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 23 23
High Test Results 17 17
Incorrect Measurement 6 6
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
Nonstandard Device 1 1
Defective Device 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 34 34
No Consequences Or Impact To Patient 7 7
No Clinical Signs, Symptoms or Conditions 7 7
No Code Available 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Tissue Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc II Sep-07-2016
2 Tosoh Bioscience Inc II Jun-05-2018
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