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Trade Name | KANEKA LIXELLE BETA 2-MICROGLOBULIN APHERESIS COLUMN |
Classification Name | beta 2-microglobulin apheresis column |
Generic Name | beta 2-microglobulin apheresis column |
Applicant |
KANEKA PHARMA AMERICA LLC |
546 fifth ave., 21st floor |
new york, NY 10036 |
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HDE Number | H130001 |
Supplement Number | S002 |
Date Received | 04/18/2016 |
Decision Date | 05/16/2016 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Changes at the osaka plant to the method of connecting and disconnecting column housings/filled columns to the processing line, method of replacing fluid in the column, method of removing air in the column and elimination of the air-tightness test of the column due to redundancy. The changes were made to reduce man-hours by introducing automated processes performed by the new machine. |