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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pacemaker, cardiac, external transcutaneous (non-invasive)
Regulation Description External transcutaneous cardiac pacemaker (noninvasive).
Product CodeDRO
Regulation Number 870.5550
Device Class 2


Premarket Reviews
ManufacturerDecision
CONMED
  SUBSTANTIALLY EQUIVALENT 2
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 2
KATECHO, INC.
  SUBSTANTIALLY EQUIVALENT 4
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL DATA ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL RESEARCH LAB., INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 1
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 10
TZ MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device displays error message 24
Failure to pace or properly pace 12
Device operates differently than expected 6
Device damaged prior to use 4
Failure to charge 3
Electrical issue 2
Failure to deliver energy 2
Output issue 2
Programming issue 1
Failure to capture 1
Device sensing issue 1
Failure of device to self-test 1
Improper device output 1
Inappropriate or unexpected reset 1
Normal 1
Output energy incorrect 1
Output above specifications 1
Component(s), worn 1
Loss of power 1
Failure to shock or properly shock 1
Total Device Problems 67

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 1 0 0
Class II 0 0 0 0 1 0 2 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II Sep-02-2015
2 Covidien LLC I Oct-15-2014
3 Covidien LLC II Apr-29-2013
4 TZ Medical Inc. II May-30-2013
5 Welch Allyn Protocol, Inc II Jan-24-2011

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