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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 NameMEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
Classification Nameheart-valve, non-allograft tissue
ApplicantMEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
PMA NumberP970031
Supplement NumberS009
Date Received08/30/1999
Decision Date09/29/1999
Product Code
LWR[ Registered Establishments with LWR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to relocate medtronic's heart valve manufacturing facility from irvine, ca, to 1851 east deere avenue, santa ana, ca.
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