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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 System, Delivery System
Generic Nameheart-valve, non-allograft tissue
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP150036
Supplement NumberS068
Date Received02/03/2023
Decision Date05/04/2023
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to extend the shelf life of the Edwards INTUITY Delivery System packaging trays from 2 to 4 years and to implement for a 4-year packaging shelf life and new peel strength test specifications for the inner and outer packaging trays.
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