Rev.
Date
A
February
Initial release of IFU for V8.3
2014
B
February
Added potential complication/outcome/adverse event per article Barbanti
2014
et al; Circulation. 2013; 128:244-253.
Updated Balloon Sizing
Inserted Aortic Structure Guideline image
Updated Balloon sizing chart formatting
Updated 19mm and 23mm balloon sizing information for 4
C
April 2014
inflation
C.1
April 2015
Updated Address. Updated Definition of Latex Free. Per ECO2015006.
C.2
April 2015
Updated with post dilatation instructions.
THIS DOCUMENT IS THE PROPERTY OF INTERVALVE INC. AND SHALL NOT BE REPRODUCED,
DISTRIBUTED, DISCLOSED OR USED FOR MANUFACTURE OR SALE OF APPARATUS WITHOUT THE
EXPRESSED WRITTEN CONSENT OF INTERVALVE INC.
LABELING, IFU, V8.3, ENGLISH
REVISION HISTORY
1204-001 Revision C.2
Description
Page 2 of 3
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