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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, spinal epidural
Product CodeLHG
Regulation Number 882.5880
Device Class 2


Premarket Reviews
ManufacturerDecision
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Hemorrhage/Bleeding 1 1

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