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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device neuromodulator for obesity
Definition Weight reduction by peripheral neuromodulation.
Product CodePIM
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 0 0 0 0 0 0 0 7 6 2

Device Problems
Device displays error message 30
Device inoperable 27
Electrical issue 16
Low impedance 14
Use of Device Issue 7
Impedance issue 6
Material twisted 4
High impedance 4
Fracture 3
No Known Device Problem 3
Prompts will not clear 3
Therapeutic or diagnostic output failure 2
Low readings 2
Migration of device or device component 2
Misconnection 1
Device stops intermittently 1
Improper or incorrect procedure or method 1
Loose or intermittent connection 1
Connection issue 1
Electrical overstress 1
Total Device Problems 129

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