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
AutoloGel System	platelet-rich plasma gel preparation kit	November 2022	Review Report	Review Report No.1 No.2

 

B

Brand Name	Term Name	Approved In	English	Japanese

 

C

Brand Name	Term Name	Approved In	English	Japanese
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

 

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
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

 

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(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.

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
IVL Generator	driving unit for atherectomy angioplasty catheter	March 2022	Review Report	Review Report

 

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(Note)

^Note 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
nodoca	endoscopic telescope disease characteristic finding detection support software for endoscope	April 2022	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
Syringe Pump Control Software for Assisting Total Intravenous Anesthesia	Software for automated drug delivery for general anesthesia	September 2022	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
Zephyr Endobronchial Valve System	endobronchial valve	November 2022	Review Report	Review Report

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