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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.

 

Tradename/
Proper Name
 
Description and Indication for DeviceSubmission IDManufacturer
 
Approval Date

CliniMACS


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.
 

110018

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

1/23/14