FDA.reportPublic FDA data

PMA P000037S028

Device
ON-X PROSTHETIC HEART VALVE
Applicant
On-X Life Technologies, Inc.
PMA number
P000037
Supplement
S028
Product code
LWQ
Decision date
2013-02-13
Classification
Heart-valve, Mechanical
Generic name
HEART-VALVE, MECHANICAL
Approval order statement
APPROVAL FOR A MODIFIED AORTIC SEWING CUFF AS AN EXTENSION TO THE LINE OF AVAILABLE VALVES; THE REQUEST APPLIED TO THE AORTIC SIZES OF 19, 21, 23, 25, AND 27/29 MM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ON-X AORTIC PROSTHETIC HEART VALVE WITH ANATOMIC SEWING RING, AND WILL BE GIVEN THE MODEL DESIGNATIONS OF ONXAN (STANDARD VALVE HOLDER) AND ONXANE (EXTENDED VALVE HOLDER).

Current openFDA PMA Record#

Device
ON-X PROSTHETIC HEART VALVE
Applicant
On-X Life Technologies, Inc.
PMA number
P000037
Supplement
S028
Product code
LWQ
Generic name
HEART-VALVE, MECHANICAL
Decision date
2013-02-13
Decision code
APPR
Date received
2012-06-28
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A MODIFIED AORTIC SEWING CUFF AS AN EXTENSION TO THE LINE OF AVAILABLE VALVES; THE REQUEST APPLIED TO THE AORTIC SIZES OF 19, 21, 23, 25, AND 27/29 MM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ON-X AORTIC PROSTHETIC HEART VALVE WITH ANATOMIC SEWING RING, AND WILL BE GIVEN THE MODEL DESIGNATIONS OF ONXAN (STANDARD VALVE HOLDER) AND ONXANE (EXTENDED VALVE HOLDER).