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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, depth
Regulation Description Depth electrode.
Product CodeGZL
Regulation Number 882.1330
Device Class 2


Premarket Reviews
ManufacturerDecision
AD-TECH
  SUBSTANTIALLY EQUIVALENT 9
FHC, INC.
  SUBSTANTIALLY EQUIVALENT 3
PMT CORP.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Known Device Problem 9
Fluid leak 1
Difficult to remove 1
Material separation 1
Total Device Problems 12

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 1 1 1 0 0 0 1 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ad-Tech Medical Instrument Corporation II Apr-15-2016
2 Ad-Tech Medical Instrument Corporation II Oct-21-2014
3 Cyberkinetics Neurotechnology Systems, Inc. II Jul-07-2009
4 FHC, Inc. II Mar-16-2010
5 FHC, Inc. II Dec-18-2008

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