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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, MODELS 995, 995MS AND 995CS
Generic Nameheart-valve, non-allograft tissue
ApplicantMedtronic, Inc.
1851 EAST DEERE AVE.
SANTA ANA, CA 92705
PMA NumberP970031
Supplement NumberS017
Date Received08/03/2006
Decision Date09/01/2006
Product Code LWR 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO THE SUPPLIER OF THE PLOYPROPYLENE RESIN USED FOR THE INJECTION MOLDING OF THE FINAL CONTAINER LIDS.
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