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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, cortical
Regulation Description Cortical electrode.
Product CodeGYC
Regulation Number 882.1310
Device Class 2


Premarket Reviews
ManufacturerDecision
AD-TECH MEDICAL INSTRUMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BLACKROCK MICROSYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
DIXI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SPES MEDICA SRL
  SUBSTANTIALLY EQUIVALENT 1
WISE S.R.L.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2022 2 2
2023 2 2
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 3 3
Difficult to Remove 2 2
Improper or Incorrect Procedure or Method 2 2
Signal Artifact/Noise 1 1
Entrapment of Device 1 1
Insufficient Information 1 1
Material Twisted/Bent 1 1
Material Protrusion/Extrusion 1 1
Device Contaminated at the User Facility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 3 3
Foreign Body In Patient 2 2
No Known Impact Or Consequence To Patient 1 1
Bacterial Infection 1 1

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