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Immunosuppressants / Macrolides / Drug-eluting stent / Medical equipment / Phosphorylcholine / Zotarolimus / Coronary stent / Restenosis / Stent / Medicine / Implants / Interventional cardiology


Review Report February 6, 2009 Pharmaceuticals and Medical Devices Agency The results of a regulatory review conducted by the Pharmaceuticals and Medical Devices Agency on the following medical device submitted for regis
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Document Date: 2014-03-31 04:12:45

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Company

Medtronic / System for Medical Devices / Johnson & Johnson / Boston Scientific Japan / Endeavor Coronary Stent System [Applicant] Medtronic Japan Co. Ltd. / In Vitro Diagnostics / Abbott Laboratories / /

Country

Guinea / Japan / United States / /

Event

FDA Phase / /

IndustryTerm

stent / bare-metal stent system / therapy for ischemic heart disease / pharmaceutical product / chemical composition / real-time samples / function replacement device / Treatment of patients with symptomatic ischemic heart disease / cardiovascular systems / lesion site / bare-metal platform stent / metal surface / control / similar medical devices / bare metal stent / /

MedicalCondition

inflammatory response / inflammatory reactions / chronic toxicity study / moderate inflammation / stent thrombosis / mild inflammation / ischemic heart disease / severe rash / symptomatic ischemic heart disease / physical irritation / vascular wall injuries / inflammatory findings / /

MedicalTreatment

immunosuppression / catheter / /

Organization

Pharmaceuticals and Medical Devices Agency / Committee on Medical Devices / FDA / /

Person

Adverse Cardiac / Labour / /

Position

Driver / Micro-Driver / Minister of Health / Major / aforementioned Driver / /

Product

paclitaxel / Micro-Driver Coronary Stent System / coronary / 21600BZY00136000 / system / Cypher stent / /

PublishedMedium

the Japanese review / /

Technology

pharmacokinetics / drug development / /

SocialTag