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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device automated breast ultrasound
Definition Adjunct to mammography for breast cancer screening and diagnosis.
Product CodePAA
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
1 0 0 1 1 0

MDR Year MDR Reports MDR Events
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3 3
Sleep Dysfunction 1 1
Speech Disorder 1 1
Inflammation 1 1
Unspecified Blood or Lymphatic problem 1 1
Paralysis 1 1
Muscular Rigidity 1 1
Discomfort 1 1
Neck Stiffness 1 1
Bacterial Infection 1 1
Breast Discomfort/Pain 1 1

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