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 with CD 34-negative tumors.
Approval Date: 7/2/99