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Table 2. FY 2008 List of Approved Products: New Medical Devices Approval Date Category 1 1
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Document Date: 2012-08-28 04:24:53

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Company

Johnson & Johnson / Medtronic Japan Co. Ltd. / MMT Co. Ltd. / Integra / Air Water Inc. / CooperVision Japan Inc. / AMO Manufacturing USA LLC / Epic HF / St. Jude Medical Japan Implantable Co. Ltd. / Fukuda Denshi Co. Ltd. / DVx Inc. / Abbott Vascular Japan Coronary stent Co. Ltd. / Carl Zeiss Meditec Co. Ltd. / Takiron Co. Ltd. / Bausch & Lomb Japan Electric keratome Co. Ltd. / JIMRO Co. Ltd. / Alcon Japan Ltd. / BIOTRONIK Japan Inc. / Notes A / B. Braun Aesculap Japan Co. Ltd. / Asahi Kasei Medical Co. Ltd. / Olympus Medical Systems Corp. / Japan Gore-Tex Inc. / Fukuda Denshi Co. / Goodman Co. Ltd. / Navistar / Yamahachi Dental MFG Co. / Japan Lifeline Co. Ltd. / JMS Co. Ltd. / US Brand Name Review / St. Jude Medical Japan Implantable cardiac Co. Ltd. / Century Medical Inc. / St. Jude Medical Japan / /

Country

Japan / /

Event

FDA Phase / /

IndustryTerm

related auxiliary devices / hemostatic device / stainless-steel balloon-expandable coronary stent / added target site / load bearing site / apheresis device / vascular lumen imaging instrument / diagnostic imaging instrument / implantable device / stenotic site / conventional product / target site / inner and outer fixation devices / ventricular autocapture algorithm / manufacturing site / laser energy / similar product / /

MedicalCondition

astigmatism / myopia / PDA / partialthickness thermal injuries / acute respiratory failure / aneurysm / cardiac failure / chronic renal failure / unexplained syncope / severe active Crohn’s disease / presbyopia / acute and chronic renal failure / arteriovenous malformations / sepsis / thoracic insufficiency syndrome / symptomatic ischemic heart diseases / I atrial flutter / respiratory failure / saline flushing / patent ductus arteriosus / continuous acute renal failure accompanying acute hemofilter hepatic insufficiency / contraction / hyperopia / corneal opacities / abdominal aortic aneurysm / symptomatic ischemic heart disease / corneal astigmatism / /

MedicalTreatment

embolization / catheter / cardiac resynchronization therapy / surgeries / apheresis / incisions / dental implant / laser ablation / hemodiafiltration / LASIK / /

Person

Zephyr SR / /

Position

physician / /

Product

Olympus Capsule / paclitaxel / Excluder Bifurcated Stent / Co / Japan / Dec / S4 / US / Taxus Libertè Stent / K / system / Clinical Data / /

ProgrammingLanguage

ONYX / /

PublishedMedium

Atlas / /

Technology

tomography / 7 algorithm / Laser System / Laser / diagnostic imaging / ventricular autocapture algorithm / modified algorithm / PDA / /

SocialTag