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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.
 
DeviceEDWARDS INTUITY Elite Valve
Generic Nameheart-valve, non-allograft tissue
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP150036
Supplement NumberS048
Date Received11/18/2019
Decision Date04/10/2020
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a manufacturing site located at Edwards Lifesciences (Singapore) Pte. Ltd, 35 Changi North Crescent, Singapore 499641 SG, to receive and process bovine pericardial tissue sacs into treated tissue heart valve leaflets.
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