| Date | Device name | Title |
|---|---|---|
| February 18, 2021 PSEHB/MDED Notification 0218 No.1 PSEHB/PSD Notification 0218 No.1 |
Drug-eluting stent for femoral artery Drug-coated balloon dilatation catheter |
Self-inspection of Package Insert for Paclitaxel-coated Balloons and Stents in the Femoropopliteal Artery [252 KB] Summary of investigation by the PMDA-1 (April 19, 2019) [310 KB] Summary of investigation by the PMDA-2 (February 18, 2021, and revised on June 30, 2021) [177 KB] |
| December 21, 2020 PSEHB/MDED Notification 1221 No.1 PSEHB/PSD Notification 1221 No.1 |
Ventilators | Self-inspection, etc. of Ventilators concerning Products Used in Combination with Them [133 KB] |