|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||FLEXTOME CUTTING BALLOON DILATATION DEVICE|
|Generic Name||catheter, transluminal coronary angioplasty, percutaneous|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Implementation of the use of a closed-loop control (feedback), in the extrusion of the tie layer of the tri-layer component.