Here begins the text.

PMDA Risk Communications (Medical devices Risk Information of ongoing evaluation)

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 has attracted attention in foreign medical devices regulatory agencies or academic societies and PMDA/MHLW has started its evaluation.

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
July 21, 2020

April 19, 2019
(Originally Posted in Japanese)
Drug-eluting stent for femoral artery
Drug-coated balloon dilatation catheter
Paclitaxel-coated Balloons and Stents in the Femoropopliteal Artery Information provided from US FDA (2019.1.17)
Information provided from US FDA (2019.3.15)
Information provided from MHRA (2019.3.15)
Information provided from ANSM (2019.3.15)
-

 

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

  • Contact us
  • Access/Map

Copyright (C) Pharmaceuticals and Medical Devices Agency, All Rights Reserved.

000046936
0
PMDA Risk Communications (Medical devices Risk Information of ongoing evaluation)
/english/safety/info-services/devices/0006.html
en