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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrical impedance spectrometer
Definition It is indicated for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologist chooses to obtain additional information when considering biopsy. It should not be used on clinically obvious melanoma. It is to be used as one element of the overall clinical assessment. The output given by the device should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to biopsy.
Product CodeONV
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
1 1 0 0 0 0

MDR Year MDR Reports MDR Events
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Stroke/CVA 1 1

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