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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
Definition Hydrolyze fats in enteral formula.
Product CodePLQ
Regulation Number 876.5985
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCRESTA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
ALCRESTA, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2018 1 1
2019 3 3
2020 4 4
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 2 2
Complaint, Ill-Defined 2 2
Respiratory Tract Infection 1 1
Obstruction/Occlusion 1 1
Low Oxygen Saturation 1 1
Missed Dose 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Inflammation 1 1
Pain 1 1
Pneumonia 1 1
Respiratory Distress 1 1
Abscess 1 1
Fever 1 1

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