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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, sampling, chorionic villus
Product CodeLLX
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

MDR Year MDR Reports MDR Events
2014 7 7
2015 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 4 4
Nonstandard Device 3 3
Data Problem 2 2
Burst Container or Vessel 1 1
Programming Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7 7
Other (for use when an appropriate patient code cannot be identified) 1 1

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