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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 995/995CS/995MS
Classification Nameheart-valve, non-allograft tissue
Generic Nameaortic root modified subcoronary bioprosthesis
Applicant MEDTRONIC INC.
PMA NumberP970031
Supplement NumberS030
Date Received10/20/2010
Decision Date11/19/2010
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 
Addition of a quality control test for an incoming raw material.
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