Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: March 19, 2008 |
The following new items were added to the CDRH web pages on March 18, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | FDA Public Health Notification: Updated Data on Mortality Associated with the Medtronic AneuRx® Stent Graft System |  |
| Medical Devices Dispute Resolution Panel Advisory Meeting, April 19, 2007 - Minutes | |
Update : 2
Subject: Enforcement Report for March 19, 2008
Enforcement Report for March 19, 2008
Wed, 19 Mar 2008 07:17:00 -0500
Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
Update : 3
Subject: FDA Warning Letters Update
You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Update : 4
Subject: Mortality Data Associated with the AneuRx® Stent Graft System - Medical Device Safety Update
Healthcare providers should be aware of a new public health notification that re-emphasizes the need for continued surveillance of patients treated with endovascular grafts and to provide updated information on the mortality risks associated with the use of the Medtronic AneuRx® Stent Graft System.
Update : 5
Subject: FDA Data Standards Update - Additional Section Headings' LOINC Codes & Names
Greetings,
The FDA Data Standards Council's website was updated Wednesday, March 19, 2008, to include eight new LOINC codes and names for section headings.
51941-3 - PACKAGE LABEL.BACK PANEL
51947-0 - PACKAGE LABEL.BOTTOM PANEL
51948-8 - PACKAGE LABEL.FLAP PANEL
51945-4 - PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
51944-7 - PACKAGE LABEL.SIDE PANEL
51943-9 - PACKAGE LABEL.SIDE PANEL.LEFT
51942-1 - PACKAGE LABEL.SIDE PANEL.RIGHT
51946-2 - PACKAGE LABEL.TOP PANEL
Here is the hyperlink to the web page with the new LOINC codes and names: http://www.fda.gov/oc/datacouncil/loinc.html
Lonnie Smith
Project Manager
Food and Drug Administration
Update : 6
Subject: Food For Life Baking Co., Inc. Recalls Spelt Bread (March 18)
Food For Life Baking Co., Inc. Recalls Spelt Bread (March 18)
Wed, 19 Mar 2008 10:18:00 -0500
Food For Life Baking Company of Corona, California is voluntarily recalling 2,241 cases of Spelt Bread (UPC# 07347200168) because they contain spelt grain which is known to be a hybrid of wheat. People who have allergies to wheat or those with Celiac Disease may run the risk of a serious or life threatening allergic reaction if they consume spelt products.
Update : 7
Subject: Williams Foods, Inc. Issues Allergy Alert on Undeclared Milk in Bass Pro Shops Uncle Buck's Light 'N Krispy Fish Batter Mixes (March 18)
Williams Foods, Inc. Issues Allergy Alert on Undeclared Milk in Bass Pro Shops Uncle Buck's Light 'N Krispy Fish Batter Mixes (March 18)
Wed, 19 Mar 2008 13:12:00 -0500
The product is sold in Bass Pro Shops Uncle Buck's labeled 22 ounce canisters and 8 ounce flexible pouches. This recall applies to the following lot numbers: 31207A11, 35107A11, 06308A11 (22 ounce canisters) and 3530716 (8 ounce pouches). Only the "Light 'n Krispy" version of the Bass Pro Shop's Uncle Buck's Fish Batter Mixes are affected by this recall.
Update : 8
Subject: FDA Approves New Medical Adhesive to Treat Burn Patients
FDA Approves New Medical Adhesive to Treat Burn Patients
Wed, 19 Mar 2008 16:01:00 -0500
The U.S. Food and Drug Administration today approved a new medical adhesive (a fibrin sealant) called Artiss for use in attaching skin grafts onto burn patients.
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