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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme packed cartridge
Regulation Description Enzyme packed cartridge.
Definition Hydrolyze fats in enteral formula.
Product CodePLQ
Regulation Number 876.5985
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCRESTA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2021 1 1
2024 3 3
2025 2 2
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Crack 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Separation 1 1
Device Dislodged or Dislocated 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Insufficient Information 2 2
Obstruction/Occlusion 1 1
Hypoglycemia 1 1

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