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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(R) HALL PROSTHETIC HEART VALVE
Classification Nameheart-valve, mechanical
Generic Nameheart valve
ApplicantMEDTRONIC VASCULAR
PMA NumberP790018
Supplement NumberS031
Date Received07/21/1997
Decision Date11/24/1997
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the controlled environment area for certain manufacturing steps.
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