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C Pulse system
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Conditional Approve Sunshine From FDA for C-Pulse IDE Device
Dec 18, 2012Sunshine Heart has obtained a conditional approval from the US Food and Drug Administration (FDA) for its investigational device exemption (IDE)) implantable heart assist device. The non-blood contacting C-Pulse Heart Assist device, ...
Tags: C-Pulse IDE Device, FDA, clinical trial
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Sunshine Heart Has Submitted an IDE Application for Regulatory Approval
Dec 18, 2012Sunshine Heart has submitted an investigational device exemption (IDE) application of its C-Pulse Heart Assist system to the US Food and Drug Administration (FDA) for approval. The basis of the IDE application is for the initiation of ...
Tags: FDA, medical system, medical technology
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Unconditional FDA Approval for C-Pulse Heart Assist Device Is Won by Sunshine
Dec 18, 2012Sunshine Heart is planning to initiate a US pivotal trial on its C-Pulse Heart Assist device in the fourth quarter of 2012, as it received an unconditional approval from the US Food Drug Administration (FDA). The CE marked system, ...
Tags: FDA, clinical trial, medical system
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Sunshine Heart Completes Two-Year Follow-up Mark for First Patient with C-Pulse System
Dec 17, 2012Sunshine Heart has completed two-year follow-up mark for first patient who was implanted with the C-Pulse Heart Assist System in the North America feasibility trial. According to the results from the first patient, it was observed that ...
Tags: Sunshine Heart, two-year follow-up mark, C-Pulse system
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FDA Conditional Approval Is Won by Sunshine New C-Pulse System Driver
Aug 6, 2012Sunshine Heart has obtained conditional approval for its new C-Pulse system driver from the US Food and Drug Administration (FDA). The new driver, which features a lighter single unit and a number of software enhancements, is designed to ...
