This webpage was developed to provide medical devices risk information which has come under review by the PMDA/MHLW. Information provided here is as follows:
Risk Information which currently foreign regulatory agencies and academic societies are closely watching alerted by studies published in scientific journals and other sources, and has also come under review by MHLW/PMDA considered relevant to medical devices marketed in Japan.
Information provided here is still under review. If you are using the following medical devices, you should NOT stop using them only on your own judgment. Consult your healthcare professional if you have any questions or concerns about these devices.
|Posted Date||Nonproprietary Name||Risk Information Ongoing Evaluation||Related Information||Investigation Results|
|February 18, 2021||Drug-eluting stent for femoral artery
Drug-coated balloon dilatation catheter
|Paclitaxel-coated Balloons and Stents in the Femoropopliteal Artery(2019.4.19)
Paclitaxel-coated Balloons and Stents in the Femoropopliteal Artery(Update)(2021.2.18)
Paclitaxel-coated Balloons and Stents in the Femoropopliteal Artery (Update) (2021.6.30)
|Information provided from US FDA (2019.1.17)
Information provided from US FDA (2019.3.15)
Information provided from US FDA (2019.8.7)
Information provided from MHRA (2019.3.8)
Information provided from MHRA (2019.6.4)
Information provided from ANSM (2019.2.27)
|Notification on self-check|