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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.
 
DeviceSTARCLOSE VASCULAR CLOSURE SYSTEM
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
ABBOTT VASCULAR DEVICES
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.
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