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. |
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Device | ON-X ASCENDING AORTIC PROSTHESIS |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | On-X Life Technologies, Inc. 1655 ROBERTS BLVD NW KENNESAW, GA 30144 |
PMA Number | P000037 |
Supplement Number | S018 |
Date Received | 01/04/2010 |
Decision Date | 01/14/2011 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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