China NMPA announced the following enterprise whose applications have acquired priority approval: Medtronic Inc. and Ustar Biotechnology Ltd.
The details of the approval as below:
| Number | Product Name | Applicant | Approved Reasons | |
| 1 | JQZ1900154 | Transmission sheath (传送鞘管) | Medtronic Inc. | This product is regarded as urgently needed for clinical use, and there is no similar product approved in China till now. (This product is a required tool for Micra's leadless pacing system implantation)
|
| 2 | CSZ1900160 | Mycobacterium tuberculosis nucleic acid detection kit (isothermal amplification - real-time fluorescence method) 结核分枝杆菌复合群核酸检测试剂盒（恒温扩增-实时荧光法） | 杭州优思达有限公司 Ustar Biotechnology Ltd. | This product is inclusive as a medical equipment listed in the national science and technology major projects. |
Link: https://www.cmde.org.cn/CL0050/19229.html
(Published on May 27, 2019)
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