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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCentriMag Circulatory Support System
Generic NameVentricular (assist) bypass
ApplicantAbbott
6035 Stoneridge Dr.
Pleasanton, CA 94588
PMA NumberP170038
Supplement NumberS013
Date Received07/03/2023
Decision Date09/14/2023
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a design change to the packaging of blood pump box of the CentriMag Circulatory Support System.
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