The following English translations of review reports are intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese originals and the translations, the former shall prevail. PMDA shall not be responsible for any consequence resulting from use of the English versions.
The review reports were selected for translation among those of new medical devices that recently received marketing approval, in consideration of relevant factors including the novelty and priority.
EN, English; JP, Japanese
|Brand Name||Generic Name||Approved In||PDF
|Adacolumn||leukocytapheresis device||June 2012|
|DuraHeart Left Ventricular Assist System||implantable ventricular assist device||December 2010|
|Endeavor Coronary Stent System||coronary stent||March 2009|
|Fetal Shunt||shunt for fetal pleural effusion||November 2011|
|GORE TAG Thoracic Aortic Stent Graft System||aortic stent grafts||March 2008|
|HAL for Medical Use (Lower Limb Type)||biosignal-responsive motor function improvement device||November 2015||1.2.3.
|Implantable Ventricular Assist System EVAHEART||implantable ventricular assist device||December 2010|| 1.
|JACE||other surgical/orthopedic materials (autologous cultured epidermis)||October 2007|
|Jarvik 2000 Implantable Ventricular Assist Device||implantable ventricular assist device||November 2013||
|SATAKE-HotBalloon Catheter||cardiac ablation catheter||November 2015|
|Wingspan Stent System||cerebral artery stent||November 2013|
|* Errata sheet. The English translation has been corrected accordingly.|