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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device surgical cardiac ablation device, for treatment of atrial fibrillation
Definition Surgical cardiac ablation for the treatment of atrial fibrillation.
Product CodeOCM
Device Class 3

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

Device Problems
No Known Device Problem 3
Failure to conduct 1
Total Device Problems 4

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