-----Original Message-----
From: U.S. Food & Drug Administration (FDA)
Sent: 11/7/2011 2:31:03 PM
To: guyperea@live.com
Subject: CDRH New Update
CDRHNew
Date: November 7, 2011
The following new items were added to the CDRH web pages on November 4, 2011. Previous CDRH New Items can be found on the CDRHNew Page.
- Summary Information for: APTIMA HPV Assay
- Consumer Information on: APTIMA® HPV Assay - P100042
- Summary Information for: Assurant® Cobalt Iliac Balloon-Expandable Stent System
- Consumer Information on: Assurant® Cobalt Iliac Balloon-Expandable Stent System - P110011
- Class I Medical Device Recall: CareFusion EnVe Ventilators
- Summary Information for: Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM
- Consumer Information on: Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM on the cobas e 601 analyzer - P110022
- Global Harmonization Task Force: New International Medical Device Regulators' Forum Statement and Announcement of First Meeting
- Consumer Information on: XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System - P110019
- Summary Information for: XIENCE PRIME and XIENCE PRIME LL Everolimus-Eluting Coronary Stent System
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