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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA
Classification Nameheart-valve, mechanical
Generic Namereplacement heart valve
ApplicantMEDICAL CARBON RESEARCH INSTITUTE, LLC (MCRI)
PMA NumberP000037
Date Received09/01/2000
Decision Date05/30/2001
Product Code
LWQ[ Registered Establishments with LWQ ]
Docket Number 01M-0270
Notice Date 06/19/2001
Advisory Committee Cardiovascular
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 onxa in the aortic position including sizes 19, 21, 23, 25, and 27/29 mm. This device is indicated for replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S031 
S032 
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