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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE 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
Supplement NumberS013
Date Received01/20/2015
Decision Date03/31/2016
Product Code
OJE[ Registered Establishments with OJE ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for changes to the temperature cycle test system used during manufacture of the centrimag right ventricular assist system.
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