federal_register: 2015-16774

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2015-16774 Acute Ischemic Stroke Medical Devices Trials Workshop; Public Workshop; Request for Comments Notice The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Acute Ischemic Stroke Medical Device Trials Workshop". Acute ischemic stroke medical devices are intended to remove blood clots from the cerebral neurovasculature by mechanical, laser, ultrasound, or a combination of technologies. The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated with acute ischemic stroke medical devices. Ideas generated during this workshop may facilitate further development of guidance regarding the content of premarket submissions for acute ischemic stroke emerging technologies and help to speed development and approval of future submissions. 2015-07-09 2015 7 https://www.federalregister.gov/documents/2015/07/09/2015-16774/acute-ischemic-stroke-medical-devices-trials-workshop-public-workshop-request-for-comments https://www.govinfo.gov/content/pkg/FR-2015-07-09/pdf/2015-16774.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Acute Ischemic Stroke Medical Device Trials Workshop". Acute ischemic stroke medical devices are intended to remove blood clots from the cerebral...  

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