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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 HALL PROSTHETIC HEART VALVE /HALL EASY FIT
Classification Nameheart-valve, mechanical
ApplicantMEDTRONIC
PMA NumberP790018
Supplement NumberS045
Date Received11/12/2003
Decision Date11/28/2003
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at biotest laboratories, inc. Minneapolis, minnesota.
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