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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
Classification Nameheart-valve, mechanical
Generic Nameheart valve
ApplicantMEDTRONIC VASCULAR
PMA NumberP790018
Supplement NumberS036
Date Received10/17/2000
Decision Date11/09/2000
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate supplier for the polytetrafluoroethylene (ptfe) fabric constructed of ptfe yarn. This fabric is used to manufacture the sewing ring component for the medtronic hall prosthetic heart valve, model a7700, sizes 20, 22, and 24 mm.
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