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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device high intensity ultrasound system for prostate tissue ablation
Definition Prostate tissue ablation
Product CodePLP
Regulation Number 876.4340
Device Class 2


Premarket Reviews
ManufacturerDecision
INSIGHTEC, INC
  SUBSTANTIALLY EQUIVALENT 1
INSIGHTEC, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROFOUND MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
PROFOUND MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 2 2
2021 1 1
2022 6 6
2023 6 6
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 14 14
Use of Device Problem 4 4
Inadequate or Insufficient Training 2 2
Insufficient Information 2 2
Device Handling Problem 2 2
Output Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Electrical /Electronic Property Problem 1 1
Difficult to Insert 1 1
Output above Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fistula 15 15
No Clinical Signs, Symptoms or Conditions 2 2
Diarrhea 1 1
Nerve Damage 1 1
Perforation 1 1
Hematuria 1 1
Fibrosis 1 1
Constipation 1 1
Urethral Stenosis/Stricture 1 1

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