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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 HALL PROSTHETIC HEART VALVE, AORTIC VALVED CONDUIT, AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT
Generic NameHEART-VALVE, MECHANICAL
ApplicantMEDTRONIC CARDIAC SURGERY
8299 CENTRAL AVE., N.E.
SPRING LAKE PARK, MN 55432-3576
PMA NumberP790018
Supplement NumberS035
Date Received08/31/1999
Decision Date09/29/1999
Withdrawal Date 12/23/2011
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
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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