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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device cover, burr hole
Regulation Description Burr hole cover.
Product CodeGXR
Regulation Number 882.5250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
NEOS SURGERY S.L.
  SUBSTANTIALLY EQUIVALENT 1
NEUROPACE INC
  SUBSTANTIALLY EQUIVALENT 1
OSSDSIGN AB
  SUBSTANTIALLY EQUIVALENT 2
ST JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 27
Adverse Event Without Identified Device or Use Problem 22
Activation, Positioning or Separation Problem 8
Unstable 7
Device Operates Differently Than Expected 4
Difficult to Open or Close 4
Device Or Device Fragments Location Unknown 3
Unintended Movement 3
Insufficient Information 2
Loose or Intermittent Connection 2
Separation Problem 1
Shelf Life Exceeded 1
Clamp 1
Material Fragmentation 1
Material Separation 1
Shipping Damage or Problem 1
Component Missing 1
Device Component Or Accessory 1
Material Integrity Problem 1
Product Quality Problem 1
Total Device Problems 92


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