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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 SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM
Classification Nameaortic valve, prosthesis, percutaneously delivered
Generic Nameaortic valve, prosthesis, percutaneously delivered
Applicant
EDWARDS LIFESCIENCES, LLC.
one edwards way
irvine, CA 92614
PMA NumberP100041
Supplement NumberS028
Date Received05/16/2013
Decision Date06/10/2013
Product Code
NPT[ Registered Establishments with NPT ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A CHANGE IN THE STENT LENGTH SPECIFICATION AND CHANGES TO THE PRODUCT LABELING WHICH INCLUDED A CHANGE TO THE LABELED LENGTH OF THE STENT AND MINOR EDITORIAL MODIFICATIONS.
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