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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
Classification Nameheart-valve, non-allograft tissue
Generic Nameheart-valve, non-allograft tissue
Applicant
Medtronic, Inc.
1851 east deere ave.
santa ana, CA 92705
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 report
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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