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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)

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A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

A

Brand Name Term Name Approved In English Japanese
Absorb GT1 Bioresorbable Vascular Scaffold System bio-absorbable coronary stent November 2016 Review Report Review Report
Adacolumn leukocytapheresis device June 2012 Review Report Review Report

 

B

Brand Name Term Name Approved In English Japanese

 

C

Brand Name Term Name Approved In English Japanese
Celution Cell Therapy Kit SUI adipose tissue separation kit February 2022 Review Report Review Report
Cool-tip RFA System E Series radiofrequency ablation system July 2018 Review Report Review Report
CureApp SC Digital Therapeutic and CO Checker for Nicotine Dependence smoking cessation treatment support system August 2020 Review Report Review Report

 

D

Brand Name Term Name Approved In English Japanese
DuraHeart Left Ventricular Assist System implantable ventricular assist device December 2010 Review Report Review Report

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E

Brand Name Term Name Approved In English Japanese
EC-PDT Probe single-use probe for PDT semiconductor laser May 2015 Review Report Review Report No.1
No.2
Endeavor Coronary Stent System coronary stent March 2009 Review Report Review Report
Espline SARS-CoV-2 SARS-CoV-2 antigen kit (IVD) May 2020 Review Summary Review Summary
Eustachian Tube Plug prosthetic material for eustachian tube May 2020 Review Report Review Report

 

F

Brand Name Term Name Approved In English Japanese
Fetal Shunt shunt for fetal pleural effusion November 2011 Review Report Review Report
FoundationOne CDx Cancer Genomic Profile software for gene variants analysis (for comprehensive genomic profiling for cancer)
software for analysis of somatic variants (for eligibility identification of antineoplastic agents)
December 2018 Review Report Review Report

 

G

Brand Name Term Name Approved In English Japanese
GORE TAG Thoracic Aortic Stent Graft System aortic stent grafts March 2008 Review Report Review Report
Gore Viabahn Stent Graft heparin-coated stent-graft for central circulatory system
heparin-coated stent-graft for blood vessels
February 2016 Review Report Review Report

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H

Brand Name Term Name Approved In English Japanese
HAL for Medical Use (Lower Limb Type) biosignal-responsive motor function improvement device November 2015 Review Report Review Report No.1
No.2
No.3
Errata sheet*

*The English translation has been corrected accordingly.

I

Brand Name Term Name Approved In English Japanese
Implantable Ventricular Assist System EVAHEART implantable ventricular assist device December 2010 Review Report Review Report No.1
No.2
No.3
No.4

 

J

Brand Name Term Name Approved In English Japanese
Jarvik 2000 Implantable Ventricular Assist Device implantable ventricular assist device November 2013 Review Report Review Report
Errata sheet*

*The English translation has been corrected accordingly.

K

Brand Name Term Name Approved In English Japanese
Kawasumi Najuta Thoracic Stent Graft System aortic stent graft December 2012 Review Report Review Report

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L

Brand Name Term Name Approved In English Japanese

 

M

Brand Name Term Name Approved In English Japanese
Matsudaito non-absorbable local hemostatic material for central circulation system December 2011 Review Report Review Report No.1
No.2
MitraClip NT System percutaneous repair system for mitral valve coaptation failure October 2017 Review Report Review Report

 

N

Brand Name Term Name Approved In English Japanese
Nerve Regeneration Guidance Conduit Nerbridge collagen-containing absorbable nerve regeneration inducing material March 2013 Review Report Review Report
NeuCure BNCT Dose Engine treatment planning program for boron neutron capture therapy March 2020 Review Report Review Report
NeuCure BNCT System neutron irradiation system for boron neutron capture therapy March 2020 Review Report Review Report

 

O

Brand Name Term Name Approved In English Japanese
OncoGuide NCC Oncopanel System gene variants analysis set (for comprehensive genomic profiling for cancer) December 2018 Review Report Review Report

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P

Brand Name Term Name Approved In English Japanese
PD Laser
Partial Change Approval
PDT semiconductor laser May 2015 Review Report Review Report No.1
No.2

 

Q

Brand Name Term Name Approved In English Japanese

 

R

Brand Name Term Name Approved In English Japanese
RETISSA Medical laser retinal scanning type eyewear January 2020 Review Report Review Report
RFA System radiofrequency ablation system July 2018 Review Report Review Report

 

S

Brand Name Term Name Approved In English Japanese
SATAKE-HotBalloon Catheter cardiac ablation catheter November 2015 Review Report Review Report
Suncon Kyoto-CS limbal-supported contact lens for abnormal corneal shape February 2016 Review Report Review Report

 

T

Brand Name Term Name Approved In English Japanese
TITANBRIDGE thyroid cartilage fixation device December 2017 Review Report Review Report

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U

Brand Name Term Name Approved In English Japanese

 

V

Brand Name Term Name Approved In English Japanese

 

W

Brand Name Term Name Approved In English Japanese
Wingspan Stent System cerebral artery stent November 2013 Review Report Review Report

 

X

Brand Name Term Name Approved In English Japanese

 

Y

Brand Name Term Name Approved In English Japanese

 

Z

Brand Name Term Name Approved In English Japanese

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JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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Review Reports: Medical Devices
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