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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device material, dressing, surgical, polylactic acid
Product CodeLPG
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
8 1 6 3 4 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 2 2
Insufficient Information 1 1
Contamination 1 1
Melted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
No Known Impact Or Consequence To Patient 1 1
Swelling/ Edema 1 1

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