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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement.
 
Device Autopheresis C Plasmapheresis System
Classification Nameseparator, automated, blood cell, diagnostic
Generic Nameautomated blood cell separators
Regulation Number864.9245
Applicant
Baxter Healthcare Corporation
1851 delaware parkway
Miami , FL 33152 
  
PMA NumberBP840001
Supplement NumberS019
Date Received10/10/1989
Decision Date04/26/1990
Decision Approved
Product Code
GKT[ Registered Establishments with GKT ]
Advisory Committee Hematology
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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