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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameATS 3F AORTIC BIOPROSTHESIS
Classification Nameheart-valve, non-allograft tissue
ApplicantMEDTRONIC ATS MEDICAL, INC.
PMA NumberP060025
Date Received09/27/2006
Decision Date10/30/2008
Product Code
LWR[ Registered Establishments with LWR ]
Docket Number 08M-0594
Notice Date 11/14/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the ats 3f aortic bioprosthesis, model 1000 (sizes 21, 23, 25, 27 and 29 mm). The device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S004 S005 S006 S007 S008 S009 S010 
S011 S012 
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