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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 NumberS025
Date Received07/02/2025
Decision Date12/01/2025
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of changes to the CentriMag Circulatory Support System Clinical Reference Manual to include information on the CentriMag FTW Post-Approval Study
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