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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.
 
DeviceSTARR-EDWARDS SILASTIC BALL HEART VALVE, MODELS 1260 AND 6120
Generic NameHEART-VALVE, MECHANICAL
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP870038
Supplement NumberS011
Date Received10/06/2006
Decision Date01/19/2007
Withdrawal Date01/28/2022
Product Code LWQ 
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 MINOR DESIGN CHANGE AND CHANGE IN MATERIAL SUPPLIER.
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