CMDE released 2017 innovation medical device special approval application review results publicity
On May 27th, the Center for Medical Device Evaluation (CMDE) of the State Food and Drug Administration issued the “Publication of the Examination Results for Special Approvals for Innovative Medical Devices (No. 5, 2017)â€. This is the result of the fifth batch of reviews published by the 2017 CMDE.
According to the public notice, two products in the fifth batch were included in the special approval. They were the pre-implantation chromosome aneuploidy detection kit (semiconductor sequencing method) and Hangzhou Yahui applied by Sikang Medical Technology (Suzhou) Co., Ltd. Surgical sealant applied by Biotechnology Co., Ltd. The publicity time is from May 27, 2017 to June 12, 2017.
The following is a summary of the results of the CMDE 2017 Innovative Medical Device Special Approval Application Review:
No. 1 of 2017
1. Product Name: Transcatheter aortic valve system
Applicant: Peijia Medical Technology (Suzhou) Co., Ltd.
2. Product Name: Bioabsorbable coronary rapamycin eluting stent system
Applicant: Shanghai Baixin Biotechnology Co., Ltd.
3. Product Name: Interventional Magnetic Resonance System
Applicant: Shanghai Ailifeng Medical Technology Co., Ltd.
4. Product Name: Low Energy Pulse Ultrasound Therapy Apparatus
Applicant: Beijing Wanli Li Medical Equipment Co., Ltd.
5. Product Name: SPACO OMX6i Medical Electron Linear Accelerator
Applicant: Guangdong Zhongneng Accelerator Technology Co., Ltd.
6. Product Name: cryo-freezing surgical system (including single-use sterile cryoablation needle)
Applicant: Haijieya (Beijing) Medical Devices Co., Ltd.
7. Product Name: Skin Photoacoustic Microscope Imager
Applicant: Guangzhou Haoting Electronic Technology Co., Ltd.
8. Product Name: Peripheral vascular stent system
Applicant: Suzhou Yinluo Medical Devices Co., Ltd.
9. Product Name: Cryofocus cryoablation system (including cryoablation equipment, cryoablation catheter)
Applicant: Kangxi Biotechnology (Shanghai) Co., Ltd.
10. Product Name: Shockwave Therapy
Applicant: Shenzhen Huikang Precision Instrument Co., Ltd.
11. Product Name: Left atrial appendage occlusion system
Applicant: Hangzhou Nuomao Medical Technology Co., Ltd.
No. 2 of 2017
1. Product Name: Drug-eluting peripheral vascular stent system
Applicant: Zhejiang Guichuang Medical Devices Co., Ltd.
2. Product Name: Hydrogen Oxygen Atomizer
Applicant: Shanghai Haomei Medical Technology Co., Ltd.
3. Product Name: Human SDC2 gene methylation detection kit (fluorescence PCR method)
Applicant: Guangzhou Kang Liming Biotechnology Co., Ltd.
4. Product Name: Neurosurgical Robot Navigation and Positioning System
Applicant: Huake Precision (Beijing) Medical Technology Co., Ltd.
5. Product Name: GNAS Gene Mutation Detection Kit
Applicant: Tianjin Jing Naite Gene Biotechnology Co., Ltd.
6. Product Name: Human EGFR gene mutation detection kit (multiplex fluorescent PCR method)
Applicant: Xiamen Aide Biomedical Technology Co., Ltd.
7. Product Name: Human cancer multi-gene mutation combined detection kit (reversible end termination sequencing method)
Applicant: Xiamen Aide Biomedical Technology Co., Ltd.
8. Product Name: Paclitaxel-eluting PTCA balloon dilatation catheter
Applicant: Zhejiang Batai Medical Technology Co., Ltd.
9. Product Name: Abdominal aortic stent graft and delivery system
Applicant: Wei Chuang Xinmai Medical Technology (Shanghai) Co., Ltd.
10. Product Name: Renal artery radiofrequency ablation catheter
Applicant: Shanghai Weichuang Electrophysiology Medical Technology Co., Ltd.
11. Product Name: Collagen cartilage regeneration carrier
Applicant: Ubiosis Co. Ltd
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