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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device continuous glucose monitor retrospective data analysis software
Definition Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device.
Product CodePHV
Regulation Number 862.2120
Device Class 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. II Sep-27-2016

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