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Trade Name | LIPOSORBER LA-15 SYSTEM |
Classification Name | apheresis for focal glomerulosclerosis in adult and pediatric patients |
Generic Name | apheresis for focal glomerulosclerosis in adult and pediatric patients |
Applicant |
KANEKA PHARMA AMERICA LLC |
546 fifth ave., 21st floor |
new york, NY 10036 |
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HDE Number | H120005 |
Supplement Number | S003 |
Date Received | 02/16/2016 |
Decision Date | 02/25/2016 |
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 A change of vendor (and manufacturing site) of brominated polycarbonate for the housing and header components in the liposorber la-15 system’s sulflux kp-05. |