Review Reports: Medical Devices

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.

Read more:
PDF Procedures for Public Release of Information on Review of Applications for New Medical Devices (PMDA Notification No. 0206007, February 6, 2009) (PDF)

EN: English, JP: Japanese   

Brand Name Generic Name Approved In PDF
EN
PDF
JP
DuraHeart Left Ventricular Assist System implantable ventricular assist device Dec. 2010 PDF PDF
Endeavor Coronary Stent System coronary stent Mar. 2009 PDF PDF
GORE TAG Thoracic Aortic Stent Graft System aortic stent grafts Mar. 2008 PDF PDF
Implantable Ventricular Assist System EVAHEART implantable ventricular assist device Dec. 2010 PDF PDF 1.
PDF 2.
PDF 3.
PDF 4.
JACE other surgical/orthopedic materials (autologous cultured epidermis) Oct. 2007 PDF PDF