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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS)
Classification Nameright ventricular bypass (assist) device
Generic Nameright ventricular bypass (assist) device
Applicant
THORATEC CORP.
23 fourth ave.
burlington, MA 01803
HDE NumberH070004
Date Received04/30/2007
Decision Date10/07/2008
Product Code
OJE[ Registered Establishments with OJE ]
Docket Number 08M0563
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S008 S010 S011 
S012 S013 S014 
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