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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceON-X PROSTHETIC HEART VALVE
Generic NameHEART-VALVE, MECHANICAL
ApplicantOn-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 
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 ProductNo
Predetermined Change Control Plan AuthorizedNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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