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Recent Additions In CDRH

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* Federal Register: Draft Guidance for Industry on Developing Coronary Drug Eluting Stents: Public Workshop.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* Federal Register: Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device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

Updated May 9, 2008

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