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发表于 2009-5-26 01:24 PM
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On 11/14/08, Nephros submitted a 510(k) application to the FDA for approval of its HDF products for ESRD in the U.S. market. The application details the Company's OLpur MD220 diafilter and OLpur H2H Hemodiafiltration module. Following its review of the application, the FDA has requested additional information. Nephros replied to the FDA inquiries on 3/13/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided by the Company for an expected decision by Friday 6/12/09 or Monday 6/15/09.
On 10/7/08, Nephros filed a 510(k) application for approval to market DSU filters to dialysis clinics for in-line purification of dialysate water. Following its review of the application, the FDA requested additional information, and Nephros provided a formal response to the agency on 2/24/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided; so a decision from the agency could come as early as Tuesday 5/26/09.
如果两个都批了,一定会1.5-2.5 |
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