|Trade Name||ACS OTW PHOTON CORONARY DILATATION CATHETER|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Generic Name||coronary dilatation catheter|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The 30-day notice requested: 1) modification of the manufacturing process by which the proximal adapter is bonded to the proximal portion of the acs otw photon(tm) coronary dilatation catheter; and 2) modification of the adaptation tensile test at the finished device audit process.