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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implant, hearing, active, middle ear, partially implanted
Product CodeMPV
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
2 2 2 4 3 1 2 1 1 2

Device Problems
Device operates differently than expected 84
No Known Device Problem 22
No device output 13
No Information 6
Device stops intermittently 3
Device inoperable 2
Output issue 2
No code available 1
Output below specifications 1
Leak 1
Migration of device or device component 1
No voice prompts 1
Cut in material 1
Device displays error message 1
Dislodged or dislocated 1
Escape 1
Extrusion 1
Improper device output 1
Total Device Problems 143

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