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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
05-24271 Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices) Notice The Food and Drug Administration (FDA) is announcing the following public meeting: Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices). The topics of discussion are the agency's activities regarding the regulation and approval of circulatory support devices used for temporary support in pediatric patients. Date and Time: The public meeting will be held on January 20, 2006, from 9 a.m. to 12 p.m. The agency is requiring registration by December 30, 2005. Location: The public meeting will be held at the Center for Devices and Radiological Health, rm. 20B, 9200 Corporate Blvd., Rockville, MD 20850. Contact: Eric Chen, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., 301-443- 8262, ext. 146, e-mail: eac@cdrh.fda.gov, or Michael Berman (HFZ-170), 12725 Twinbrook Pkwy., 301-827-4744, e-mail: mrb@cdrh.fda.gov. If you need special accommodations due to a disability, please contact Eric Chen, at least 7 days in advance of the meeting. Registration: There is no fee to attend the workshop; however, because space is limited, registration is required. Please submit registration information (including name, title, firm name, address, e- mail address, telephone number, and fax number) by December 30, 2005 (see Contact). Background information for the workshop will be available to the public on the Internet at http://www.fda.gov/cdrh/ meetings/012006workshop/index.html. 2005-12-20 2005 12 https://www.federalregister.gov/documents/2005/12/20/05-24271/regulatory-process-for-pediatric-mechanical-circulatory-support-devices-ventricular-assist-devices https://www.govinfo.gov/content/pkg/FR-2005-12-20/pdf/05-24271.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the following public meeting: Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices). The topics of discussion are the agency's activities regarding the...

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