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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pulse generator, external pacemaker, dual-chamber
Regulation Description External pacemaker pulse generator.
Definition A dual chamber external pacemaker is intended to provide temporary dual chamber cardiac pacing as a substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats following cardiac surgery or a myocardial infarction.
Product CodeOVJ
Regulation Number 870.3600
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 1 2 0 0 0 0

Device Problems
Failure to capture 1
Disconnection 1
Failure to pace or properly pace 1
No code available 1
Total Device Problems 4

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