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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 NumberS015
Date Received02/17/2016
Decision Date03/16/2016
Product Code
OJE[ Registered Establishments with OJE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Implementation of a supplier facility relocation for a component used in the centrimag right ventricular assist system.
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