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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.
 
DeviceON-X PROSTHETIC HEART VALVE
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
On-X Life Technologies, Inc.
1655 roberts blvd nw
kennesaw, GA 30144
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/material
Expedited Review Granted? No
Combination Product No
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
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