Vaccines, Blood & Biologics

2014 Humanitarian Device Exemption (HDE)

This list reflects information regarding the applications as of the approval/clearance date. It is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval / clearance.

2014 Humanitarian Device Exemption (HDE)
Proper Name
Description and Indication for Device Submission ID Manufacturer Approval Date


Stem Cell Separation System

CD34 Reagent System.
For processing hemtopoietic progenitor cells-apheresis (HPC-A) to obtain a CD34+ cell enriched population
intended to provide for hematopoietic reconstitution following a myeloablative preparative regimen without the need
for additional graft-vs-host disease (GVHD) prophylaxix in patients with Acute Myeloid Leukemia (AML) in first or second morphologic complete remission.


Miltenyi Biotec, Inc.
120 Presidential Way
Suite 305
Woburn, MA 01801


Page Last Updated: 03/23/2015
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