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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, RETROFLEX 3 DELIVERY SYSTEM,RETROFLEX BALLOON CATHETER
Classification Nameaortic valve, prosthesis, percutaneously delivered
Generic Namereplacement heart valve
ApplicantEDWARDS LIFESCIENCES LLC.
PMA NumberP110021
Supplement NumberS002
Date Received11/21/2012
Decision Date12/11/2012
Product Code
NPT[ Registered Establishments with NPT ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use of jar torque machines.
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