Premarket Approval Information - Devices
Product: DACS SC (Buoyant Density Solution 60)
Applicant: Dendreon Corp., Seattle, WA
PMA number: BP970003
Indication for Use: Processing autologous mobilized peripheral blood progenitor cells (PBPC) collected by leukapheresis to reduce RBC, platelets and granulocytes in the final PBPC product.
Approval Date: 7/23/99
Letter -
(PDF),
(Text)
Label - (PDF)
Summary - (PDF)
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