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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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New Search Biologics Premarket Approvals (PMAs) Back to Search Results
Note: this medical device record is a supplement.
 
Device Isolex 300 Magnetic Cell Separation System
Classification Namesystem, separation, hematopoietic stem cell
Generic Namestem cell separation system
Applicant
Baxter Healthcare Corporation
9 parker
Irvine , CA 92618 
PMA NumberBP970001
Supplement NumberS046
Date Received05/08/2008
Decision Date12/04/2008
Decision Approved
Product Code
MZK
Advisory Committee Hematology
Supplement Type135 Day Track for 30 Day Notification
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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