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Announcement on Review Results for Medical Devices’ Priority Approval Application (2019 No.6)

2019-05-30 14:15

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

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)

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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