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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 NumberS020
Date Received03/02/2020
Decision Date08/17/2020
Withdrawal Date12/13/2021
Product Code NPT 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for implementation of a Visual Standard to aid operators in distinguishing between acceptable and rejectable surface defects on the Multi-Lumen Extrusion (MLE) of the Lotus Edge Valve System.
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