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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
Classification Nameheart-valve, non-allograft tissue
Generic Nameaortic root modified subcoronary bioprosthesis
ApplicantMEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
PMA NumberP970031
Supplement NumberS019
Date Received07/02/2007
Decision Date11/29/2007
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a borate buffered saline (bbs) solution pre-rinse to the p5 amino-oleic acid (aoa) process.
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