|Trade Name||EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER|
|Classification Name||device, angioplasty, laser, coronary|
|Generic Name||coronary angioplasty catheter|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change to an adhesive primer used in the manufacture of the elca eccentric (ell) devices. Previously, you have used loctite 793 which has been discontinued by the vendor. The primer has been changed to loctite 7701, a medical grade adhesive primer used for the same purpose.