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IDEImpuesto a Depósitos en Efectivo (Spanish: Tax Cash Deposits)
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IDEIstituto Dermatologico Europeo (Italy)
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References in periodicals archive ?
Microvascular company Micro Medical Solutions (MMS) reported on Monday the receipt of US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to evaluate MicroStent's safety and efficacy to restore blood flow and reduce amputations from CLI and PAD diseases under a US pivotal clinical STAND trial.
Because of safety concerns in that age group, carotid artery stenting would be allowed in this group only when it is performed in a Food and Drug Administration Category B Investigational Device Exemption trial, an FDA-approved postapproval study, or under Medicare clinical trial policy.
If finalized, the proposal would replace current CMS policy that patients at high risk for carotid endarterectomy (CEA) with asymptomatic carotid artery stenosis of greater than 80% can be covered only when carotid artery stenting procedures are performed in an FDA Category B Investigational Device Exemption trial, an FDA-approved postapproval study, or in accordance with Medicare clinical trial policy.
Under the amended Supply and Services Agreement, PPTI, on behalf of Spine Wave, is proceeding with preclinical safety and performance studies of the device to support Spine Wave's filing of an Investigational Device Exemption with the U.S.
Within the next few months, Radiance intends to file for an Investigational Device Exemption ("IDE") with the United States Food and Drug Administration ("FDA") to expand the enrollment in the United States to begin a Phase I Study.
How are breast implants studied under the Investigational Device Exemption (IDE)?
To get FDA approval for a device, you need to do studies, and to do studies, you need an investigational device exemption (IDE).
However, as part of the FDA approval process, the devices can be used clinically in a limited number of patients under a very specific protocol known as an "investigational device exemption" (IDE).
"Finalizing the Investigational Device Exemption, or IDE, with the FDA is an important step towards the future availability of the EVO Visian ICL family of products in the U.S."
M2 EQUITYBITES-June 25, 2019-Micro Medical Solutions awarded FDA Investigational Device Exemption (IDE) approval to evaluate MicroStent for CLI and PAD
M2 PHARMA-June 25, 2019-Micro Medical Solutions awarded FDA Investigational Device Exemption (IDE) approval to evaluate MicroStent for CLI and PAD
Additionally, the company has received unconditional IDE (Investigational Device Exemption) approval to initiate a pivotal clinical study to treat patients with moderate to severe chronic obstructive pulmonary disease (COPD) with chronic bronchitis (CB).
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