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PMDA
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Japanese Approval for Jarvik 2000 Heart Is Announced by Jarvik Heart
Dec 9, 2013Jarvik Heart, a manufacturer of cardiac assist devices, has announced the Shonin approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the Jarvik 2000 heart, a small left ventricular assist device implanted inside ...
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Aerocrine Announced That Japanese Approved The Use of Its Feno-Measuring Device
Nov 26, 2013Aerocrine, a medical products company, has announced that Japanese health authorities have approved the use of its FeNO-measuring device NIOX MINO as a tool for assessing patients with airway inflammation such as asthma. On 19 November ...
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Pillcam SB 3 System Was Acquire by Given Imaging of Japanese Approval
Sep 24, 2013Given Imaging, a manufacturer of gastrointestinal medical devices, has obtained an approval from the Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for its third-generation PillCam SB 3 system, which can detect small bowel ...
Tags: Pillcam SB 3 System
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Century Medical Sought Clearance From Pmda for Microcutter XCHANGE 30 Cutting
Aug 15, 2013Century Medical, a Japanese medical device distributor, has sought clearance from the country's Pharmaceuticals and Medical Devices Agency (PMDA) for Cardica's MicroCutter XCHANGE 30 cutting and stapling cartridge, which is intended for ...
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Symetis Announced Its Systems Have Been Successfully Implanted in Patients in Japan
Aug 13, 2013Symetis has announced its Acurate TA and Acurate TF TAVI systems have been successfully implanted in patients in Japan as part of a feasibility study to secure the Pharmaceutical and Device Agency's (PMDA) pre-market approval. Based on a ...
Tags: Symetis, TAVI Systems
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Merit Medical Received Multiple Regulatory Approvals From Various Regulatory Bodies
Jul 4, 2013Merit Medical, US-based cardiology, radiology and endoscopy disposable devices manufacturer and distributor, has received multiple regulatory approvals from various regulatory bodies. Merit's advanced high-pressure inflation device, ...
Tags: Merit Medical, Medical Devices
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Adachi Medical Instrument Shas Placed an Order for Renaissance Surgical Guidance System
Dec 18, 2012Adachi Medical Instruments, Mazor Robotics' distribution partner in Japan, has placed an order for Renaissance surgical guidance system. Renaissance is a minimally invasive device designed for use in spine procedure including ...
Tags: Adachi Medical, surgical guidance system, medical device
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Nipro Enters Into a Agreement to Distribute Infraredx's TVC Intravascular Imaging System
Dec 14, 2012Nipro has entered into a five-year agreement to distribute Infraredx's TVC intravascular imaging system for true vessel characterization of coronary artery disease in Japan. The TVC imaging system incorporates near infrared ...
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Sorin Group Has Obtained Marketing Rights to Heart Valve, Following The Approval From PMDA
Dec 10, 2012Sorin Group has obtained marketing rights to its Mitroflow aortic pericardial heart valve in Japan, following the approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The bioprosthetic heart valve, which is ...
Tags: PMDA, heart valve, Japan Lifeline
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Mitsubishi Tanabe Pharma Has Deployed ArisGlobal's New Pharmacovigilance
Nov 29, 2012Mitsubishi Tanabe Pharma has deployed ArisGlobal's new pharmacovigilance and clinical safety solutions including ARISg and ARISj. ARISg and ARISj solutions are designed for collecting, assessing, distributing and managing adverse ...
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Patient Enrollment Is Completed by Terumo in Osprey Trial
Jul 12, 2012Terumo Interventional Systems has completed enrolling patients in its Occlusive/Stenotic Peripheral Artery REvascularization StudY (OSPREY). The MISAGO stent comprises a nitinol stent pre-mounted on the distal portion of a rapid-exchange ...
Tags: OSPREY Trial, Misago Stent system, superficial femoral artery
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