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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.
 
DeviceMasters Series, Masters Series HP, Regent, Masters Series Aortic Valved Graft with Hemashield graft technology
Generic NameHEART-VALVE, MECHANICAL
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP810002
Supplement NumberS121
Date Received01/23/2024
Decision Date04/03/2024
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
for implementing rebranding of the SJM Masters Series Mechanical Heart Valve, SJM Regent Mechanical Heart Valve, and SJM Masters Valved Graft with Hemashield graft technology.
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