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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, surgical, cryogenic
Product CodeGXH
Regulation Number 882.4250
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRICURE INC.
  SUBSTANTIALLY EQUIVALENT 1
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PACIRA BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PACIRA PHARMACEUTICALS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 4 4
2021 6 6
2022 3 3
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Temperature Problem 4 4
Tear, Rip or Hole in Device Packaging 3 3
Device Dislodged or Dislocated 2 2
Output Problem 2 2
Use of Device Problem 2 2
No Apparent Adverse Event 1 1
Activation Failure 1 1
Gas/Air Leak 1 1
Moisture or Humidity Problem 1 1
Detachment of Device or Device Component 1 1
Insufficient Cooling 1 1
Crack 1 1
Fluid/Blood Leak 1 1
Energy Output Problem 1 1
Material Separation 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cryogenic Burn 5 5
No Clinical Signs, Symptoms or Conditions 5 5
No Patient Involvement 3 3
No Known Impact Or Consequence To Patient 2 2
Pain 2 2
Inadequate Pain Relief 2 2
Burn, Thermal 1 1
Electric Shock 1 1
Visual Impairment 1 1
Respiratory Insufficiency 1 1
Decreased Sensitivity 1 1
Burn(s) 1 1

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