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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device aspiration therapy system
Definition Percutaneous gastric implant to remove stomach contents after eating for weight loss in the treatment of obesity in adults
Product CodeOYF
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 5 1 4 1 1 0 0 0 0

MDR Year MDR Reports MDR Events
2017 2 2
2018 1 1
2019 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 2 2
Torn Material 1 1
Cut In Material 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
Missing Value Reason 1 1
Abscess 1 1

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