Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)
Medical specialty
Unknown
Device class
f
Review panel
HE
Implant
Y
Life sustaining/supporting
Y
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.