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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameRETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLON CATHETER, EDWARDS TRANSFEMORAL BALLON CATHETER, CRIMPER
Classification Nameaortic valve, prosthesis, percutaneously delivered
Generic Namereplacement heart valve
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP100041
Supplement NumberS027
Date Received04/23/2013
Decision Date05/22/2013
Product Code
NPT[ Registered Establishments with NPT ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
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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