| Document Date: 2010-10-20 06:19:12
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Company Materials Regulatory Corporation / Regulatory Japan Co. Ltd. / Bausch & Lomb Japan / Pump Change Instrument & (Medtronic Japan Co. Ltd. / Johnson & Johnson / Dornier MedTech Japan Co. Ltd. / Boston Scientific Japan / Medtronic Japan Co. Ltd. / HOYA Reusable Corporation / Getz Bros Co. / Epic HF / Alcon Japan Ltd. / Japan Tissue Engineering Other Co. Ltd. / Menicon Co. Ltd. / Japan Gore-Tex Inc. / Goodman Co. Ltd. / Navistar / GUNZE Limited / Regulatory Ltd. / Bioresorbable Ltd. / Toray Regulatory Industries Inc. / Sysmex Corporation / Edwards Lifesciences LLC / Nidek Co. Ltd. / Cosmotec Co. Ltd. / Pump Approval Instrument & (Medtronic Japan Co. Ltd. / Hitachi Ltd. / SEED Co. Ltd. / Aquacel Ag / AMO Manufacturing / Given Imaging Ltd. / Koken Co. Ltd / Biomet Microfixation Inc. / St. Jude Medical / Bristol-Myers Squibb / Nihon Bionics Co. Ltd. / / Country Japan / / Event FDA Phase / Reorganization / Natural Disaster / / IndustryTerm manufacturing approval / conventional products / balanced saline solution / diagnostic imaging system / beam energy / ceramic and metal layers / femoral artery puncture site / diagnostic imaging instrument / atelocollagen solution / ophthalmic products / local hemostatic device / ultrasound imaging / ventricular assist device / medical device / low-energy extracorporeal shock wave therapy system / conventional product / processed human cellullar/tissue product / trade products / radiotherapy system using high-energy proton beam / ablation site / days imaging instrument / intravascular ultrasonic diagnostic imaging / sound processing strategy / / MedicalCondition astigmatism / myopia / extracapsular cataract / aneurysm / acute and chronic renal failure / chronic plantar fasciitis / sleep apnea syndrome / thoracic aortic aneurysm / burns / nonresectable liver tumors / carotid stenosis / arrhythmia / aqueous tear deficiency / burn / I atrial flutter / cataracts / hyperopia / corneal opacities / pain / abdominal aortic aneurysm / ventricular fibrillation/tachycardia / anemia / Cataract / atrial fibrillation/tachycardia / severe and moderate anemia / / MedicalTreatment photorefractive keratectomy / balloon catheter / PRK / angioplasty / Laser-assisted in situ keratomileusis / radiotherapy / surgery / embolization / Proton beam therapy / total hip replacement / PTCA / cochlear implant / catheter / Cardiac Resynchronization Therapy / cautery / catheterization / hip replacement / laser ablation / Hemodialysis / cardioversion / hemodiafiltration / Cataract Surgery / LASIK / / OperatingSystem XP / / Position applicable programmer / controller / / Product Airy One Approval Instrument / baclofen / BSS / Artery Stent / C174AWK / 21500BZY00342000 / O2OPTIX / UV-1 / Boston Stent / Aortic stent / Clinical Data / / PublishedMedium Atlas / / Technology tomography / diagnostic imaging system / ultrasound / laser / Diagnostic Imaging / /
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Table 2. FY2007 List of Approved Products: New Medical Devices Category Approval Date Review time