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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.
 
DeviceHANCOCK MODIFIED ORIFICE, MODIFIED ORIFICE II AORTIC BIOPROSTHESES
Classification Nameheart-valve, non-allograft tissue
Generic Nameheart-valve, non-allograft tissue
Applicant
MEDTRONIC HEART VALVES
1851 east deere ave.
santa ana, CA 92705
PMA NumberP790007
Supplement NumberS016
Date Received08/31/1999
Decision Date09/29/1999
Product Code
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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