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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.
 
DeviceSILASTIC BALL HEART VALVE PROSTHESIS
Generic NameHEART-VALVE, MECHANICAL
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP870038
Supplement NumberS010
Date Received09/26/2006
Decision Date01/18/2007
Withdrawal Date 01/28/2022
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGING THE NUMBER OF TURNS PER METER TO THE SEWING THREAD.
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