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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.
 
DeviceRETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLON CATHETER, EDWARDS TRANSFEMORAL BALLON CATHETER, CRIMPER
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 NumberS027
Date Received04/23/2013
Decision Date05/22/2013
Product Code
NPT[ Registered Establishments with NPT ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR ADDITION OF POLYETHYLENE FOAM TO THE BASE OF THE CRIMPER DURING PACKAGING, A CHANGE TO THE CRIMPER PACKAGE RELEASE TEMPERATURE SET POINT, AND ADDITION OF POUCH INTEGRITY INSPECTIONS FOR ALL SAPIEN ACCESSORIES.
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