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.
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 |
Brand Name | Term Name | Approved In | English | Japanese |
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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 |
AutoloGel System | platelet-rich plasma gel preparation kit | November 2022 | Review Report | Review Report No.1 No.2 |
Brand Name | Term Name | Approved In | English | Japanese |
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Brand Name | Term Name | Approved In | English | Japanese |
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C2 Coronary IVL Catheter | atherectomy ablative angioplasty catheter | March 2022 | Review Report | Review Report |
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 HT Digital Therapeutic App for Hypertension Adjunctive Treatment | supporting software for hypertension treatment | April 2022 | 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 |
Brand Name | Term Name | Approved In | English | Japanese |
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DuraHeart Left Ventricular Assist System | implantable ventricular assist device | December 2010 | Review Report | Review Report |
Brand Name | Term Name | Approved In | English | Japanese |
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EC-PDT Probe | single-use probe for PDT semiconductor laser | May 2015 | Review Report | Review Report No.1 No.2 |
Edwards SAPIEN 3 Partial Change Approval |
transcatheter bovine cardiac valve | September 2022 | Review Report | Review Report |
Endeavor Coronary Stent System | coronary stent | March 2009 | Review Report | Review Report |
ENROUTE Transcarotid Neuroprotection System | catheter for embolic capture in the central circulation system | October 2022 | Review Report | Review Report No.1 No.2 |
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 |
Brand Name | Term Name | Approved In | English | Japanese |
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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 |
Brand Name | Term Name | Approved In | English | Japanese |
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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 |
Brand Name | Term Name | Approved In | English | Japanese |
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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(Note) |
Harmony Transcatheter Pulmonary Valve Replacement System | Transcatheter porcine pericardial valve | August 2021 | Review Report | Review Report |
Note The English translation has been corrected accordingly.
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 |
IVL Generator | driving unit for atherectomy angioplasty catheter | March 2022 | Review Report | Review Report |
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(Note) |
Note The English translation has been corrected accordingly.
Brand Name | Term Name | Approved In | English | Japanese |
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Kawasumi Najuta Thoracic Stent Graft System | aortic stent graft | December 2012 | Review Report | Review Report |
Brand Name | Term Name | Approved In | English | Japanese |
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Brand Name | Term Name | Approved In | English | Japanese |
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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 |
Brand Name | Term Name | Approved In | English | Japanese |
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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 |
nodoca | endoscopic telescope disease characteristic finding detection support software for endoscope |
April 2022 | Review Report | Review Report |
Brand Name | Term Name | Approved In | English | Japanese |
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OncoGuide NCC Oncopanel System | gene variants analysis set (for comprehensive genomic profiling for cancer) | December 2018 | Review Report | Review Report |
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 |
Brand Name | Term Name | Approved In | English | Japanese |
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Brand Name | Term Name | Approved In | English | Japanese |
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RETISSA Medical | laser retinal scanning type eyewear | January 2020 | Review Report | Review Report |
RFA System | radiofrequency ablation system | July 2018 | Review Report | Review Report |
Brand Name | Term Name | Approved In | English | Japanese |
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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 |
Syringe Pump Control Software for Assisting Total Intravenous Anesthesia | Software for automated drug delivery for general anesthesia | September 2022 | Review Report | Review Report |
Brand Name | Term Name | Approved In | English | Japanese |
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TITANBRIDGE | thyroid cartilage fixation device | December 2017 | Review Report | Review Report |
Brand Name | Term Name | Approved In | English | Japanese |
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Brand Name | Term Name | Approved In | English | Japanese |
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Brand Name | Term Name | Approved In | English | Japanese |
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Wingspan Stent System | cerebral artery stent | November 2013 | Review Report | Review Report |
Brand Name | Term Name | Approved In | English | Japanese |
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Brand Name | Term Name | Approved In | English | Japanese |
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Brand Name | Term Name | Approved In | English | Japanese |
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Zephyr Endobronchial Valve System | endobronchial valve | November 2022 | Review Report | Review Report |