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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 CARDIAC VALVE PROSTHESIS
Classification Nameheart-valve, mechanical
Generic Namemechanical heart valve
ApplicantMEDICAL, INC.
PMA NumberP830039
Supplement NumberS009
Date Received12/08/1998
Decision Date12/30/1998
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
1. Mixture of sterilant gas for the ethylene oxide gas now used 2. A change in the vehicle for the bacillus subtilis var. Niger biological indicator samples used for sterility 3. Reduction of the incubation time of the biological indicators.
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