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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 PMA to get an up-to-date view of this device.
 
DeviceSYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
Classification Nameartificial heart
Generic Nameartificial heart
Applicant
SYNCARDIA SYSTEMS, INC.
1992 e. silverlake rd.
tucson, AZ 85713
PMA NumberP030011
Supplement NumberS019
Date Received02/11/2013
Decision Date05/30/2013
Product Code
LOZ[ Registered Establishments with LOZ ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for expansion of your controlled environment suite manufacturing area.
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