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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 PROSTHETIC HEART VALVE
Classification Nameheart-valve, mechanical
Generic Namereplacement heart valve
ApplicantMEDICAL CARBON RESEARCH INSTITUTE, LLC (MCRI)
PMA NumberP000037
Supplement NumberS001
Date Received09/07/2001
Decision Date03/06/2002
Product Code
LWQ[ Registered Establishments with LWQ ]
Docket Number 02M-0255
Notice Date 06/05/2002
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the on-x prosthetic heart valve, model onxm in sizes 25 mm, 27/29 mm, 31/33 mm, and model onxmc in size 25/33 mm in the mitral position. This device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the mitral position.
Approval Order Approval Order
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