CDRHNew
Date: October 24, 2013
The following new items were added to the CDRH web pages on October 23, 2013. Previous CDRH New Items can be found on the CDRHNew Page.
- CDRHLearn Presentation: IDEs for Early Feasibility Medical Device Clinical Studies, Including First in Human (FIH) Studies (PDF - 105kb)
- Class I Medical Device Recall: Codman and Shurtleff MedStream Programmable Infusion Pump and Refill Kits - Drug Over Infusion
- Class I Medical Device Recall: Draeger Medical Fabius Series Anesthesia Machines - Failure of Automatic Ventilation
- Federal Register: Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
- July 2013 PMA Approvals
- Summary Information for: Liposorber® LA-15 System
- Consumer Information on: Liposorber® LA-15 System - H120005
- Meeting Announcement: November 8, 2013 Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee
- Transcript posted for September 11, 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
- Transcript posted for September 12, 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
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