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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
3200 lakeside drive
santa clara, CA 95054
PMA NumberP050007
Supplement NumberS003
Date Received07/05/2006
Decision Date09/22/2006
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: 1) increasing the radii of the distal end of the support tube (clip delivery tube) from 0. 002 inches to 0. 004 inches; 2) adding a 45 degree chamfer to the proximal edge of the distal ring; and 3) removing the ?6f? notation on the handle of the device.