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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 NameMEDTONIC FREESTYLE AORTIC BIOPROSTHESIS
Classification Nameheart-valve, non-allograft tissue
Generic Namereplacement heart valve
ApplicantMEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
PMA NumberP970031
Supplement NumberS007
Date Received10/02/1998
Decision Date10/30/1998
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested a change in the method in which a raw material (aoa compound) is synthesized. This will result in the raw material being received in a more purified form. The quality control test performed in incoming inspection will change from the gravimetric test method to the ninhydrin test method.
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