According to the CFDA Trial Center issued a notice, the center organized experts to conduct a review of a "drug eluting balloon" products is preferred to apply for examination and approval, the project is in accordance with the prior approval of the case, intended to be a priority for approval, and the publicity, publicity time for April 2017 - 21 - 27.
Without accident, this medical device will soon be given priority approval, and this is our country since January this year to open the priority examination and approval channel since the first approval of the third products.
Prior to this, in February of this year and March, respectively, 1 medical devices have priority approval, the reasons are included in the national key R & D plan".
Unlike the previous 2 medical devices, the reason for the approval of the drug eluting balloon catheter is "clinically urgent", and there is no medical device approved for registration in the same species in our country".
It is reported that the drug eluting balloon catheter is produced by Liaoning Yinyi biological Polytron Technologies Inc R & D, the product can be used for coronary bifurcation lesions, is the company's first priority into medical equipment approval.