CDRHNew
Date: July 16, 2014
The following new items were added to the CDRH web pages on July 15, 2014. Previous CDRH New Items can be found on the CDRHNew Page.
- 24 Hour Summary posted for July 10-11, 2014 Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting
- Federal Register: Benefit-Risk Factors To Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] With Different Technological Characteristics; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Federal Register: Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Availability
- Summary Information for: Edwards SAPIEN XT Transcatheter Heart Valve
- Consumer Information on: Edwards SAPIEN XT Transcatheter Heart Valve - P130009
- FDA Voice Blog: Developing new tools to support regulatory use of 'Next Gen Sequencing' data
- Summary Information for: Fluency Plus Endovascular Stent Graft
- Consumer Information on: Fluency Plus Endovascular Stent Graft - P130029
- May 2014 PMA Approvals
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