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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device diagnostic low electric field
Definition As an adjunctive tool to guide the shavings of tissue at the margins of the tumor for use in excisional breast surgery to assist in locating the tissue for excision. In addition to other standard methods such as intraoperative imaging and palpation.
Product CodeOEE
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
3 1 0 1 0 0

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