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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, Crimper
Generic NamePulmonary valve prosthesis percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP200015
Supplement NumberS010
Date Received06/07/2021
Decision Date06/29/2021
Product Code NPV 
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 Technology SARL, Hwy #402 N Km 1.4, Añasco, Puerto Rico for ethylene oxide (EO) sterilization of the Commander Delivery System and Crimper accessory for the SAPIEN 3 Transcatheter Heart Valve System.
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