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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device magnetic cell selection system for cd34+ cells from hpc-apheresis used in treatment of acute myeloid leukemia (aml)
Definition For processing hematopoietic progenitor cells-apheresis (HPC-A) from an HLA-identical donor to obtain a CD34 positive cell enriched population that will provide for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft-vs-host disease (GVHD) prophylaxis.
Product CodeOVG
Device Class Humanitarian Device Exemption


Premarket Reviews
ManufacturerDecision
MILTENYI BIOTEC, INC.
  APPROVED 5
  30 DAY - NO 75 DAY SUPPLEMENT NEEDED 13

MDR Year MDR Reports MDR Events
2019 2 2
2020 2 2
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 4 4
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Abdominal Pain 1 1
Bacterial Infection 1 1
Death 1 1
Dyspnea 1 1
Foreign Body Reaction 1 1
Renal Failure 1 1

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