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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)

Brand Name Term Name Approved In English Japanese
Adacolumn leukocytapheresis device June 2012 Review Report Review Report(Japanese)
Cool-tip RFA System E Series radiofrequency ablation system July 2018 Review Report Review Report(Japanese)
DuraHeart Left Ventricular Assist System implantable ventricular assist device December 2010 Review Report Review Report(Japanese)
Endeavor Coronary Stent System coronary stent March 2009 Review Report Review Report(Japanese)
Fetal Shunt shunt for fetal pleural effusion November 2011 Review Report Review Report(Japanese)
GORE TAG Thoracic Aortic Stent Graft System aortic stent grafts March 2008 Review Report Review Report(Japanese)
HAL for Medical Use (Lower Limb Type) biosignal-responsive motor function improvement device November 2015 Review Report Review Report(Japanese) No.1
No.2
No.3
Errata sheet*
Implantable Ventricular Assist System EVAHEART implantable ventricular assist device December 2010 Review Report Review Report(Japanese) No.1
No.2
No.3
No.4
Jarvik 2000 Implantable Ventricular Assist Device implantable ventricular assist device November 2013 Review Report Review Report(Japanese)
Errata sheet*
Kawasumi Najuta Thoracic Stent Graft System aortic stent graft December 2012 Review Report Review Report(Japanese)
RFA System radiofrequency ablation system July 2018 Review Report Review Report(Japanese)
SATAKE-HotBalloon Catheter cardiac ablation catheter November 2015 Review Report Review Report(Japanese)
Suncon Kyoto-CS limbal-supported contact lens for abnormal corneal shape February 2016 Review Report Review Report(Japanese)
TITANBRIDGE thyroid cartilage fixation device December 2017 Review Report Review Report(Japanese)
Wingspan Stent System cerebral artery stent November 2013 Review Report Review Report(Japanese)

*The English translation has been corrected accordingly.

JCN 3010005007409

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Chiyoda-ku, Tokyo 100-0013 Japan

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Review Reports: Medical Devices
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