|Trade Name||CORDIS PRECISE NITINOL STENT SYSTEM & RX NITINOL STENT & PRO RX NITINOL STENT SYSTEM|
|Classification Name||stent, carotid|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for reducing the sample size for the following processes: 1) the fusing operation for all precise devices and the sealing operation for precise rx; and 2) the bonding process of the precise rx and precise pro rx support member/wire lumen subassembly.