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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 NumberS021
Date Received10/02/2024
Decision Date11/01/2024
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
changes to the manufacturing process flow, rework procedure, and cup height inspection procedure related to the updated locking feature
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