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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameFREESTYLE AORTIC ROOT BIOPROSTHESIS, MODELS 995, 995MS AND 995CS
Classification Nameheart-valve, non-allograft tissue
Generic Nameaortic root modified subcoronary bioprosthesis
ApplicantMEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
PMA NumberP970031
Supplement NumberS017
Date Received08/03/2006
Decision Date09/01/2006
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
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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