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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device catheter, balloon, urethral, drug-coated
Definition Dilate urethral strictures
Product CodeQRH
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 0 0 0 0 1 6 1 1

MDR Year MDR Reports MDR Events
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Pressure Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Fistula 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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