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

EN, English; JP, Japanese

Brand Name Generic Name Approved In PDF
EN
PDF
JP
Adacolumn leukocytapheresis device June 2012 PDF PDF
DuraHeart Left Ventricular Assist System implantable ventricular assist device December 2010 PDF PDF
Endeavor Coronary Stent System coronary stent March 2009 PDF PDF
Fetal Shunt shunt for fetal pleural effusion November 2011 PDF PDF
GORE TAG Thoracic Aortic Stent Graft System aortic stent grafts March 2008 PDF PDF
HAL for Medical Use (Lower Limb Type) biosignal-responsive motor function improvement device November 2015 PDF PDF1.PDF2.PDF3.
PDF*
Implantable Ventricular Assist System EVAHEART implantable ventricular assist device December 2010 PDF PDF 1.
PDF 2.
PDF 3.
PDF 4.
JACE other surgical/orthopedic materials (autologous cultured epidermis) October 2007 PDF PDF
Jarvik 2000 Implantable Ventricular Assist Device implantable ventricular assist device November 2013 PDF PDF
PDF*
SATAKE-HotBalloon Catheter cardiac ablation catheter November 2015 PDF PDF
Wingspan Stent System cerebral artery stent November 2013 PDF PDF
* Errata sheet. The English translation has been corrected accordingly.

JCN 3010005007409

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Review Reports: Medical Devices
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