definiens: means only changes in 1 ) balloon diameter, 2)balloon length, 3 ) balloon size, 4 ) balloon material, 5 ) the inner and outerdimensions of the catheter shaft, 6 ) or the addition of coatings 7 ) hubs, 8)shaft length and material, 9 ) 4 < PAGE > balloon markers, or 10 ) minor components required by the FDA as a result of aproduct defect or complaint . In no event shall any other change, addition, ordeletion be deemed a Minor Modification and, in particular, any design orstructural change, addition or deletion . By way of example but not limitation, in no event shall a change in the length of the guidewire lumen to anything lessthan the full length of the catheter be deemed a Minor Modification . In no eventshall the inclusion of any means which permit a guidewire to exit the cathetershaft between the distal end and proximal end of the catheter be deemed a MinorModification