FDA.reportPublic FDA data

PMA P000037S018

Device
ON-X ASCENDING AORTIC PROSTHESIS
Applicant
On-X Life Technologies, Inc.
PMA number
P000037
Supplement
S018
Product code
LWQ
Decision date
2011-01-14
Classification
Heart-valve, Mechanical
Generic name
HEART-VALVE, MECHANICAL
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.

Current openFDA PMA Record#

Device
ON-X ASCENDING AORTIC PROSTHESIS
Applicant
On-X Life Technologies, Inc.
PMA number
P000037
Supplement
S018
Product code
LWQ
Generic name
HEART-VALVE, MECHANICAL
Decision date
2011-01-14
Decision code
APPR
Date received
2010-01-04
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
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.