On November 15th, the CFDA Medical Device Technology Review Center was organized by the Innovative Medical Device Review Office in accordance with the requirements of the State Food and Drug Administration's “Special Approval Process for Innovative Medical Devices (Trial)†(Food and Drug Administration [2014] No. 13). Experts reviewed the application for special approval for innovative medical devices, and agreed to enter the special approval process for the following application projects, which are now publicized.
1. Product Name: sacral nerve stimulation system
Applicant: Hangzhou Commitment Medical Technology Co., Ltd.
2. Product Name: Fully Degradable Polymer Matrix Drug (Rapamycin) Eluting Stent System
Applicant: Lepu (Beijing) Medical Devices Co., Ltd.
3. Product Name: Endovascular Tomography Catheter
Applicant: Nanjing Wolfman Medical Technology Co., Ltd.
4. Product Name: Fully automatic chemiluminescence immunoassay analyzer
Applicant: Beijing Lianzhong Tektronix Technology Co., Ltd.
5. Product Name: Wireless cardiac pacemaker and system
Applicant: St.Jude Medical
Puyang Degren Medical Equipment Co., Ltd. , https://www.degrenyuwei.com