|Trade Name||ROTABLATOR SYSTEM/ROTALINK PLUS/ROTALINK ADVANCER & EXCHANGEABLE CATHETER|
|Classification Name||catheter, coronary, atherectomy|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for: 1) change from in-house moulding of four components to an outsourced moulding vendor; 2) a change in the moulding gate design and location; 3) change in moulding machine; and 4) change in the inspection process for the components.