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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFREESTYLE AORTIC ROOT BIOPROSTHESIS
Generic Nameheart-valve, non-allograft tissue
ApplicantMedtronic, Inc.
1851 E. Deere Ave.
Santa Ana, CA 92705
PMA NumberP970031
Supplement NumberS050
Date Received09/21/2015
Decision Date10/21/2015
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A PRECAUTION TO INSTRUCTIONS FOR USE LABELING.
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