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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lipoprotein, low density, removal
Product CodeMMY
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
3 3 1 2 3 0

MDR Year MDR Reports MDR Events
2022 1 1
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abdominal Pain 2 2
Syncope/Fainting 1 1
Hypersensitivity/Allergic reaction 1 1
Anaphylactoid 1 1
Loss of consciousness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Kaneka America Corp II Apr-09-2022
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