| May 8, 2008 |
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Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Slides |
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PMA Final Decisions for April 2008 |
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| May 7, 2008 |
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Summary Information for: Thoratec HeartMate IIĀ® Left Ventricular Assist System (LVAS) |
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| May 6, 2008 |
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Guidance for Industry and FDA Staff: Administrative Procedures for CLIA Categorization |
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Consumer Information on: Thoratec HeartMate II LVAS - P060040 |
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| May 5, 2008 |
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510(k) Final Decisions - April 2008 |
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| May 1, 2008 |
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Federal Register: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. |
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| April 30, 2008 |
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Federal Register: Towards an Artificial Pancreas: A Food and Drug Administration, National Institutes of Health, Juvenile Diabetes Research Foundation Public Workshop. |
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Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Listing Information for Medical Device Registration and Listing. |
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| April 28, 2008 |
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Federal Register: Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Reopening of Comment Period. |
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| April 25, 2008 |
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FDA Clears Glove Made from New Type of Latex |
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| April 24, 2008 |
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Summary Information for: CONTAK RENEWAL® 3 AVT® Models M150, M155, M157 and M159 |
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Federal Register: Draft Guidance for Industry on Developing Coronary Drug Eluting Stents: Public Workshop. |
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Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations. |
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Guidance for Industry and FDA Staff: Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions (Updated 4/24/2008) |
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Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting. |
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Summary Information for: Talent™ Abdominal Stent Graft System |
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| April 22, 2008 |
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Federal Register: Agency Information Collection Activites; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking. |
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| April 18, 2008 |
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Federal Register: Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance With Section 402(j) |
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Guidance for Industry and FDA Staff: Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis |
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Guidance for Industry and FDA Staff: Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs |
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| April 17, 2008 |
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Consumer Information on: Talent™ Abdominal Stent Graft System - P070027 |
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| April 11, 2008 |
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Consumer Information on: CONTAK RENEWAL® 3 AVT® Models M150, M155, M157 and M159 - P010012S037 |
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| April 10, 2008 |
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Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification, Form FDA 3602A. |
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FDA & YOU - News for Health Educators and Students - Spring 2008 |
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Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, July 17, 2007 - Minutes |
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Radiological Devices Panel Advisory Meeting, March 4-5, 2008 - Minutes |
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