|Trade Name||ANGIOLINK VASCULAR CLOSURE SYSTEM|
|Classification Name||device, hemostasis, vascular|
|Generic Name||vascular hemostasis device|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for incorporation of the following processing and material changes to the distal end of the vcs 1000 dilator: 1) change in the dilator material from nylon 11 to pebax nylon 4033 for the dilator distal tip and from nylon 11 to pebax nylon 6033 for the dilator distal shaft; 2) addition of a rf and/or alternative thermal energy source to bond the dilator distal tip to the distal shaft; and 3) addition of a heat shrink sleeve to enhance the bond between the shaft and the distal tip.