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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 /HALL EASY FIT
Generic NameHEART-VALVE, MECHANICAL
ApplicantMEDTRONIC CARDIAC SURGERY
8299 CENTRAL AVE., N.E.
SPRING LAKE PARK, MN 55432-3576
PMA NumberP790018
Supplement NumberS045
Date Received11/12/2003
Decision Date11/28/2003
Withdrawal Date 12/23/2011
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOTEST LABORATORIES, INC. MINNEAPOLIS, MINNESOTA.
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