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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.
 
DeviceLotus Edge Valve System
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantBoston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752-1234
PMA NumberP180029
Supplement NumberS019
Date Received12/09/2019
Decision Date12/11/2019
Withdrawal Date 12/13/2021
Product Code NPT 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Changes to the adaptive seal component of the 25-mm and 23-mm LOTUS Edge Valve.
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