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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, esophageal
Product CodeESW
Regulation Number 878.3610
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
COOK IRELAND LTD
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND LTD.
  SUBSTANTIALLY EQUIVALENT 1
ENDOCHOICE, INC.
  SUBSTANTIALLY EQUIVALENT 1
M.I. TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
M.I. TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
M.I.TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
TAEWOONG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THORACENT, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 169 169
2015 175 175
2016 153 153
2017 87 87
2018 86 86
2019 167 167
2020 155 155
2021 33 33

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Aug-31-2010
2 Boston Scientific Corporation II Jun-25-2010
3 Taewoong Medical Co., Ltd. II Feb-14-2020
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