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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, anti-gastroesophageal reflux
Product CodeLEI
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 3 5 3 4 4 1 6 2 1 0 6 2 1

MDR Year MDR Reports MDR Events
2014 42 42
2015 57 57
2016 92 92
2017 133 133
2018 202 202
2019 280 280
2020 135 135

Recalls
Manufacturer Recall Class Date Posted
1 Torax Medical, Inc. II May-31-2018
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