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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, dermal, for aesthetic use
Product CodeLMH
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013
15 50 37 19 21 44 13

Device Problems
No Known Device Problem 269
Needle, separation 46
Spillage, accidental 40
Detachment of device or device component 5
Not Applicable 1
Break 1
Unknown (for use when the device problem is not known) 1
Invalid sensing 1
Migration of device or device component 1
Total Device Problems 365

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 0
Class III 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Merz Aesthetics, Inc. II Nov-01-2011
2 Merz Aesthetics, Inc. III May-19-2011

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