|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||MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Generic Name||ptca catheter|
|Applicant||MEDTRONICS INTERVENTIONAL VASCULAR|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of an accessory device, the folio balloon shaping tool, to your currently marketed line of medtronic (r) millenia(tm) coronary balloon dilatation catheters.