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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 NameMEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
Classification Nameheart-valve, non-allograft tissue
Generic Namereplacement heart valve
ApplicantMEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
PMA NumberP970031
Supplement NumberS004
Date Received01/12/1998
Decision Date09/18/1998
Product Code
LWR[ Registered Establishments with LWR ]
Docket Number N
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the protocols to be used for the short term and long term post approval studies.
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