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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.
 
DeviceRX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
Classification Namestent, carotid
Generic Namestent, carotid
Applicant
ABBOTT VASCULAR
3200 lakeside drive
santa clara, CA 95054
PMA NumberP040012
Supplement NumberS008
Date Received02/24/2006
Decision Date03/27/2006
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes: 1) addition of a new catheter leak test to the manufacturing process; 2) modifications to the radio force in-process testing parameters; 3) increasing the stringency of the aql for the distal junction test; 4) addition of a microscopic visual inspection step to detect broken struts; and 5) addition of an inspection step to verify that the adhesive was correctly applied and completely cured.
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