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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
Marborough, MA 01752
PMA NumberP180029
Supplement NumberS001
Date Received05/06/2019
Decision Date06/04/2019
Withdrawal Date12/13/2021
Product Code NPT 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Transfer of component-level tissue fixation and tissue solution manufacturing activities to a different manufacturing facility.
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