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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.
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
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.