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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.
 
Trade NameRX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS
Classification Namestent, carotid
Generic Namecarotid stent system and embolic protection system
ApplicantABBOTT VASCULAR-VASCULAR SOLUTIONS
PMA NumberP040012
Supplement NumberS010
Date Received02/28/2006
Decision Date03/14/2006
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for removal of stent mass as a final product specification for the rx acculink carotid stent system and modification of the specifications regarding allowable contaminant in the device packaging.
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