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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 NumberS023
Date Received08/02/2006
Decision Date09/01/2006
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the product acceptance audit procedure for the rx acculink and acculink carotid stent systems.
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