|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||CORONARY FLEXTOME CUTTING BALLOON|
|Generic Name||catheter, transluminal coronary angioplasty, percutaneous|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to the manufacturing process equipment by implementing an alternate bioslide coating machine, with updated hardware, software, and processing changes, as well as a minor rearrangement of the existing production equipment to new locations within the current manufacturing line.