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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) [59.25 KB]

Browse by letter

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

 

A

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
Absorb GT1 Bioresorbable Vascular Scaffold System Bio-absorbable coronary stent November 2016 English [838.15 KB] Japanese [11.75 MB]
Adacolumn Leukocytapheresis device June 2012 English [175.87 KB] Japanese [330.93 KB]
AutoloGel System Platelet-rich plasma gel preparation kit November 2022 English [692.40 KB] Japanese
No.1 [4.59 MB]

Japanese No.2 [7.00 MB]

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C

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
C2 Coronary IVL Catheter Atherectomy ablative angioplasty catheter March 2022 English [670.29 KB] Japanese [1.74 MB]
Celution Cell Therapy Kit SUI Adipose tissue separation kit February 2022 English [1.23 MB] Japanese [6.35 MB]
ClotTriever Thrombectomy System Catheter for non-central circulatory embolectomy December 2023 English [703.69 KB] Japanese [855.89 KB]
Cool-tip RFA System E Series
Initial Approval
Radiofrequency ablation system July 2018 English [628
.94 KB]
Japanese [644.06 KB]
Cool-tip RFA System E Series
Partial Change Approval
Radio-frequency ablation system July 2023 English [686.87 KB] Japanese No.1 [5.81 MB]
Japanese No.2 [6.86 MB]
CureApp HT Digital Therapeutic App for Hypertension Adjunctive Treatment Supporting software for hypertension treatment April 2022 English [658.62 KB] Japanese [4.96 MB]
CureApp SC Digital Therapeutic and CO Checker for Nicotine Dependence Smoking cessation treatment support system August 2020 English [857.50 KB] Japanese [808.47 KB]

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D

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
Duolith SD1 Ultra
Partial Change Approval
Extracorporeal shockwave skin ulcer treatment device December 2022 English [508.62 KB] Japanese [2.68 MB]
DuraHeart Left Ventricular Assist System Implantable ventricular assist device December 2010 English [373.54 KB] Japanese [5.13 MB]

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E

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
EC-PDT Probe Single-use probe for PDT semiconductor laser May 2015 English [1.13 MB] Japanese
No.1 [63.65 KB]

Japanese No.2 [698.78 KB]
Edwards SAPIEN 3
Partial Change Approval
Transcatheter bovine cardiac valve September 2022 English [951.33 KB] Japanese [2.11 MB]
EluNIR Drug-Eluting Stent Coronary stent October 2021 English [669.95 KB] Japanese [1.06 MB]
Endeavor Coronary Stent System Coronary stent March 2009 English [310.97 KB] Japanese [1.49 MB]
ENROUTE Transcarotid Neuroprotection System Catheter for embolic capture in the central circulation system October 2022 English [710.54 KB] Japanese
No.1 [2.23 MB]

Japanese No.2 [9.35 MB]
Espline SARS-CoV-2(Note 2) SARS-CoV-2 antigen kit (IVD) May 2020 English [208.43 KB] Japanese [88.89 KB]
Eustachian Tube Plug Prosthetic material for eustachian tube May 2020 English [830.39 KB] Japanese [1000.82 KB]

Note 2 Review Summary

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F

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
Fetal Shunt Shunt for fetal pleural effusion November 2011 English [163.10 KB] Japanese [633.10 KB]
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 English [410.20 KB] Japanese [2.68 MB]

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G

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
GORE TAG Thoracic Aortic Stent Graft System Aortic stent grafts March 2008 English [331.02 KB] Japanese [3.01 MB]
Gore Viabahn Stent Graft Heparin-coated stent-graft for central circulatory system
heparin-coated stent-graft for blood vessels
February 2016 English [616.16 KB] Japanese [8.04 MB]

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H

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
HAL for Medical Use (Lower Limb Type) Biosignal-responsive motor function improvement device November 2015 English [10.25 MB] Japanese
No.1 [9.64 MB]

Japanese No.2 [9.58 MB]
Japanese No.3 [10.25 MB]
Errata sheet (JP) [33.67 KB](Note 1)
Harmony Transcatheter Pulmonary Valve Replacement System Transcatheter porcine pericardial valve August 2021 English [1.02 MB] Japanese [5.00 MB]

Note 1 The English translation has been corrected accordingly.

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I

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
Implantable Ventricular Assist System EVAHEART Implantable ventricular assist device December 2010 English [380.80 KB] Japanese
No.1 [916.29 KB]

Japanese No.2 [869.65 KB]
Japanese No.3 [835.58 KB]
Japanese No.4 [498.45 KB]
IVL Generator Driving unit for atherectomy angioplasty catheter March 2022 English [670.38 KB] Japanese [1.74 MB]

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J

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
Jarvik 2000 Implantable Ventricular Assist Device Implantable ventricular assist device November 2013 English [411.49 KB] Japanese [1.29 MB]
Errata sheet (JP) [84.17 KB](Note 1)

Note 1 The English translation has been corrected accordingly.

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K

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
Kawasumi Najuta Thoracic Stent Graft System Aortic stent graft December 2012 English [1.42 MB] Japanese [755.81 KB]

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M

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
Matsudaito Non-absorbable local hemostatic material for central circulation system December 2011 English  [658.93 KB] Japanese
No.1 [8.77 MB]

Japanese No.2 [10.84 MB]
Medtronic Percept PC
Partial Change Approval
Tremor brain electrical stimulator July 2023 English [1.13 MB] Japanese [3.20 MB]
MitraClip NT System Percutaneous repair system for mitral valve coaptation failure October 2017 English [1.01 MB] Japanese [2.82 MB]

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N

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
Nerve Regeneration Guidance Conduit Nerbridge Collagen-containing absorbable nerve regeneration inducing material March 2013 English [273.29 KB] Japanese [650.21 KB]
NeuCure BNCT Dose Engine Treatment planning program for boron neutron capture therapy March 2020 English [2.31 MB] Japanese [2.54 MB]
NeuCure BNCT System Neutron irradiation system for boron neutron capture therapy March 2020 English [2.31 MB] Japanese [2.53 MB]
nodoca Endoscopic telescope
disease characteristic finding detection support software for endoscope
April 2022 English [841.19 KB] Japanese [4.50 MB]

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O

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
OncoGuide NCC Oncopanel System Gene variants analysis set (for comprehensive genomic profiling for cancer) December 2018 English [254.23 KB] Japanese [520.11 KB]

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P

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
PD Laser
Partial Change Approval
PDT semiconductor laser May 2015 English [1.13 MB] Japanese
No.1 [63.65 KB]

Japanese No.2 [698.78 KB]

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R

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
Relivion Transcutaneous peripheral nerve stimulator for head December 2023 English [667.83 KB] Japanese [10.01 MB]
RETISSA Medical Laser retinal scanning type eyewear January 2020 English [1.09 MB] Japanese [1.21 MB]
RFA System Radiofrequency ablation system July 2018 English [593.61 KB] Japanese [10.40 MB]

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S

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
SATAKE-HotBalloon Catheter Cardiac ablation catheter November 2015 English [535.72 KB] Japanese [6.17 MB]
Suncon Kyoto-CS Limbal-supported contact lens for abnormal corneal shape February 2016 English [593.74 KB] Japanese [737.03 KB]
SUSMED Med CBT-i App for Insomnia Software for insomnia February 2023 English [767.20 KB] Japanese [1.75 MB]
Synfolium Synthetic myocardial patch July 2023 English [535.01 KB] Japanese [2.03 MB]
Syringe Pump Control Software for Assisting Total Intravenous Anesthesia Software for automated drug delivery for general anesthesia September 2022 English [625.56 KB] Japanese [2.62 MB]

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T

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
TITANBRIDGE Thyroid cartilage fixation device December 2017 English [463.81 KB] Japanese [766.77 KB]
Toraymyxin Endotoxin removal adsorption hemoperfusion column December 2023 English [847.19 KB] Japanese [5.31 MB]
TRUPULSE Generator Percutaneous cardiac coagulation/ablation electrosurgical unit December 2023 English [1.12 MB] Japanese [5.37 MB]

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V

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
VARIPULSE Pulsed Field Ablation Catheter Catheter for cardiac ablation December 2023 English [1.12 MB] Japanese [5.36 MB]

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W

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
Wingspan Stent System Cerebral artery stent November 2013 English [380.81 KB] Japanese [610.55 KB]

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Z

Brand Name Term Name Approved In Review Report (EN) Review Report (JP)
Zephyr Endobronchial Valve System Endobronchial valve November 2022 English [1.36 MB] Japanese [1.47 MB]
Zilver Vena Venous Stent Venous stent December 2022 English [1.17 MB] Japanese [8.81 MB]

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