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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, cortical
Regulation Description Cortical electrode.
Product CodeGYC
Regulation Number 882.1310
Device Class 2


Premarket Reviews
ManufacturerDecision
AD-TECH
  1
  SUBSTANTIALLY EQUIVALENT 5
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 1
PMT CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Material separation 4
Device operates differently than expected 2
Improper device output 1
Output issue 1
Noise, Audible 1
No voice prompts 1
Device alarm system issue 1
Energy output to patient tissue incorrect 1
No device output 1
Total Device Problems 13

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

Recalls
Manufacturer Recall Class Date Posted
1 Ad-Tech Medical Instrument Corporation I Mar-02-2013
2 CareFusion 209 Inc. I Jan-26-2012
3 Integra Burlington MA, Inc. II Apr-01-2013

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