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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceANGIOLINK VASCULAR CLOSURE SYSTEM
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
Medtronic Vascular
37a cherry hill drive
danvers, MA 01923
PMA NumberP040022
Supplement NumberS003
Date Received03/08/2007
Decision Date05/24/2007
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product 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.
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