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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameFREEDOM SOLO STENTLESS HEART VALVE
Classification Nameheart-valve, non-allograft tissue
ApplicantSORINGROUP
PMA NumberP130011
Date Received05/16/2013
Decision Date06/24/2014
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Clinical Trials NCT00876525
NCT01115907
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the freedom solo stentless heart valve and solo smart stentless heart valve. These devices are indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
Approval Order Approval Order
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