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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 NameEDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Classification Nameaortic valve, prosthesis, percutaneously delivered
Generic Namereplacement heart valve
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP100041
Supplement NumberS022
Date Received02/12/2013
Decision Date03/12/2013
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 additional visual inspection steps for and removal, if found, of fibers and particles on sub-assembled and final assembled replacement heart valves prior to packaging.
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