Premarket Approval Information - Devices
Product: Stem Cell Concentration System
Applicant: CellPro, Inc. Bothell, WA
PMA number: BP940001
Indication for use: For the processing of autologous bone marrow to obtain a CD34+cell enriched population which is intended for hematopoietic support after myeloablative chemotherapy.
Approval Date: 12/6/96
Letter -
(PDF),
(Text)
Summary -
(PDF)
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