|Trade Name||RAPTORAIL PTCA DILATATION CATHETER (RX)|
|Classification Name||catheters, transluminal coronary angioplasty, percutaneous|
|Generic Name||percutaneous transluminal angioplasty catheter|
|Supplement Type|| Special Supplement|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the quality plan: 1) the addition of a 100% visual marker band placement verification; 2) the addition of a qc audit for marker band placement verification; and 3) the addition of a qc functional test for inflation/deflation time verification.