|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 BALLON|
|Applicant||Boston Scientific Corp.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of alternate manufacturing equipment to test for balloon leaks in the device.