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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Nameheart-valve, non-allograft tissue
Generic Nameheart-valve, non-allograft tissue
1851 east deere ave.
santa ana, CA 92705
PMA NumberP970031
Date Received07/14/1997
Decision Date11/26/1997
Product Code
LWR[ Registered Establishments with LWR ]
Docket Number 98M-0906
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Medtronic FREESTYLE(R) Aortic Root Bioprosthesis, Model 995; sizes 19, 21, 23, 25, 27 mm; implantation techniqures, subcoronary, full-root, and root inclusion; and the FREESTYLE(R) Aortic Obturators, Model 7990 and the Medtronic Handle, Model 0791. This device is a replacement heart valve and is indicated for the replacement of malfunctioning native or prosthetic aortic valves with the optio of aortic root replacement.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S003 S004 S005 S006 S007 S008 S009 S010 S011 
S013 S014 S015 S017 S019 S020 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 S032 S034 
S035 S036 S037 S038 S039 S040 S041 S042 S043 
S044 S045 S046 S047 S048 S049 S050 S051 S052 
S053 S054 S055 S056