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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device generator, pulse, pacemaker, external programmable
Regulation Description External programmable pacemaker pulse generator.
Product CodeJOQ
Regulation Number 870.1750
Device Class 2


Premarket Reviews
ManufacturerDecision
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K844815  CORDIS ELECTROPHYSIOLOGY STIMULATOR
EP MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
EP TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
MICROPACE PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 2
ST CARDIO TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 7
Electro-magnetic interference (EMI) 3
Energy output to patient tissue incorrect 1
Device displays error message 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 0 0 0 0 0 0 0 0 0
Class III 0 0 1 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 St. Jude Medical III Jun-12-2009

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