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Premarket Approval Information - Devices

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Product: Isolex 300 & 300i Magnetic Cell Selection System
Applicant: Nexell Therapeutics, Inc., Irvine, CA
PMA number: BP970001 & BP970001 Supplement 01
Indication for Use: Processing autologuous peripheral blood progenitor cell (PBPC) products to obtain a CD 34+ cell enriched population intended for hematopoietic reconstitution after myeloablative therapy in patients wiht CD 34-negative tumors.
Approval Date: 7/2/99

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Letter (PDF), (Text)

Label (PDF)

Summary (PDF)

 

Updated March 17, 2001
 
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