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Trade Name | KANEKA LIPOSORBER APHERESIS 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 | S002 |
Date Received | 11/02/2015 |
Decision Date | 02/19/2016 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | postapproval study protocol - osb |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the following changes to the post-approval study for the device: changes to one of the exclusion criteria that is related to the minimum weight requirement for the eligibility to participate in the study. |