|Trade Name||IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS ANGIOPLASTY BALLOON CATHETER|
|Classification Name||drug-eluting peripheral transluminal angioplasty catheter|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The addition of a new cleanroom for a coating procedure as well as the relocation of the outer packing process.