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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.
 
DeviceON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
On-X Life Technologies, Inc.
1655 roberts blvd nw
kennesaw, GA 30144
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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 S030 S031 S032 S033 S035 S036 S037 
S038 S039 S040 S041 S043 S044 S045 S046 
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