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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 NameON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, MODEL ONXAC
Classification Nameheart-valve, mechanical
Generic Namereplacement heart valve
ApplicantMEDICAL CARBON RESEARCH INSTITUTE, LLC (MCRI)
PMA NumberP000037
Supplement NumberS002
Date Received04/16/2002
Decision Date10/11/2002
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modified aortic sewing cuff as an extension to the line of available valves; the request applied to the aortic sizes 19, 21, 23, 25, and 27/29 mm. The device, as modified, will be marketed under the trade name on-x conform-x aortic prosthetic heart valve and will be given the model designation of model onxac and is indicated for replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position.
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