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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, bone growth, non-invasive
Product CodeLOF
Device Class 3


Premarket Reviews
ManufacturerDecision
ETHICON
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
2 2 4 1 9 2 3 7 7 4

Device Problems
No Information 8
No Known Device Problem 7
Patient-device incompatibility 5
Total Device Problems 20

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