|Trade Name||ACS SWAP-IT GUIDE WIRE EXCHANGE DEVICE CATHETER|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Generic Name||coronary dilatation catheter|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for acs swap-it(tm) guide wire exchange device which is an accessory to guidant acs rx (rail) catheters. This device will be marketed under the trade name acs swap-it(tm) guide wire exchange device and is indicated for use within a guiding catheter to facilitate the exchange of a 0. 014 inch guide wire while maintaining the position of an acs rx(r) (rail) catheter.