Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)
OVG · f · Unknown
Classification
FDA Product Code
OVG
Device class
f
Regulation
—
Review panel
HE
Medical specialty
Unknown
Submission type
6
GMP exempt
N
Life sustaining
Y
Implant
Y
Third-party review
N
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.