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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device expander, skin, inflatable
Product CodeLCJ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SURGITEK
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Implant, removal of 6
Deflation, cause unknown 5
Not Applicable 3
No code available 1
Explanted 1
Hole in material 1
Rupture, cause unknown 1
Total Device Problems 18

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