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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 NameMONOSTRUT CARDIAC VALVE PROSTHESIS
Classification Nameheart-valve, mechanical
Generic Namereplacement heart valve
ApplicantALLIANCE MEDICAL TECHNOLOGIES, INC.
PMA NumberP970002
Supplement NumberS001
Date Received03/02/1998
Decision Date03/23/1998
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
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