Product code
OVG: Magnetic cell selection system for cd34+ cells from hpc-apheresis used in treatment of acute myeloid leukemia (aml)
FDA product code · HDE · Hematology
Key facts
| Product code | OVG |
|---|---|
| Device | Magnetic cell selection system for cd34+ cells from hpc-apheresis used in treatment of acute myeloid leukemia (aml) |
| Device class | HDE |
| Review panel | Hematology |
| Submission type | HDE - Humanitarian Device Exemption |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | Yes |
| 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. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- 1–9 HDE approvals
- 1–9 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database