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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 EXPANDABLE INTRODUCER SHEATH SET
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP130009
Supplement NumberS035
Date Received05/18/2015
Decision Date06/17/2015
Product Code NPT 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
MODIFICATIONS TO THE SHEATH AND MARKER BAND MANUFACTURING PROCESS AND INSPECTIONS.
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