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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:


NumberProduct NameApplicantApproved Reasons

Transmission sheath


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)



Mycobacterium tuberculosis nucleic acid detection kit (isothermal amplification - real-time fluorescence method)



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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