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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 NameOMNISCIENCE AND OMNICARBON CARDIAC VALVES
Classification Nameheart-valve, mechanical
Generic Namemechanical heart valve
ApplicantMEDICAL, INC.
PMA NumberP830039
Supplement NumberS008
Date Received07/22/1998
Decision Date09/25/1998
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to various cleaning methods utilized during production of the omniscience(r) valve to remove chlorofluorocarbon solvents.
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