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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 Commander Delivery System
Generic NamePulmonary valve prosthesis percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP200015
Supplement NumberS026
Date Received08/09/2022
Decision Date03/09/2023
Product Code NPV 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the following manufacturing sites to conduct ethylene oxide sterilization of the Commander Delivery System (Models 9600LDS23, 9750CM23, 9600LDS26, and 9750CM26): (1) Sterigenics, Belgium, located at Zoning Industriel de Petit-Rechain Avenue Andre Ernst 21 Verviers Liege, B-4800 BE, and (2) STERIS Tullamore, located at IDA Business and Technology Park, Tullamore Offaly, IE R35 X865
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