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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 BIOPROTHESIS MODEL 995
Classification Nameheart-valve, non-allograft tissue
Generic Nameaortic root modified subcoronary bioprosthesis
ApplicantMEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
PMA NumberP970031
Supplement NumberS015
Date Received03/27/2006
Decision Date08/28/2006
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the instructions for use (ifu) based on the results of the completed post-market study for the device.
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