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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 VALVE
Generic NameHEART-VALVE, MECHANICAL
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP870038
Supplement NumberS004
Date Received12/15/2000
Decision Date01/05/2001
Withdrawal Date01/28/2022
Product Code LWQ 
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  
CHANGE IN THE PACKAGING DESIGN FROM A TWO-PIECE MOLDED POLYSULFONE CANISTER TO A THERMOFORMED POLYCARBONATE TRAY WITH INSERT AND TYVEK LID.
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