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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 ASCENDING AORTIC PROSTHESIS
Generic NameHEART-VALVE, MECHANICAL
ApplicantOn-X Life Technologies, Inc.
1655 Roberts Blvd. NW
Kennesaw, GA 30144
PMA NumberP000037
Supplement NumberS018
Date Received01/04/2010
Decision Date01/14/2011
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT VASCUTEK, LTD., SCOTLAND, GREAT BRITAIN (UK). ALSO APPROVAL FOR A VALVED CONDUIT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER HE TRADE NAME ON-X ASCENDING AORTIC PROSTHESIS AND IS INDICATED FOR THE REPLACEMENT OF A DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC HEART VALVE IN THE AORTIC POSITION IN CASES THAT INVOLVE AN ASCENDING AORTIC ANEURYSM OR OTHER ASSOCIATED AORTIC DISEASE.
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