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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.
Classification Namereplacement heart-valve
Generic Namereplacement heart-valve
Regulation Number870.3925
1851 e. deere avenue
santa ana, CA 92705
PMA NumberP870078
Supplement NumberS005
Date Received08/31/1999
Decision Date09/29/1999
Product Code
DYE[ Registered Establishments with DYE ]
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.