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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device expander, skin, inflatable
Product CodeLCJ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 2
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
LIFECELL CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 2
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 10
SILIMED
  SUBSTANTIALLY EQUIVALENT 1
SPECIALTY SURGICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 4
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SURGITEK
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Leak 7
Implant, removal of 6
Deflation, cause unknown 5
Not Applicable 5
No code available 3
No Known Device Problem 2
Deflation issue 2
Device expiration issue 1
Explanted 1
Hole in material 1
Inflation issue 1
Material integrity issue 1
Rupture, cause unknown 1
Use of Device Issue 1
Total Device Problems 37

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 1 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Allergan Inc II Jul-18-2015
2 Mentor Texas, LP. II Sep-10-2016
3 Mentor Texas, LP. II Sep-07-2016

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