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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM
Classification Namestent, carotid
Generic Namestent, carotid
Applicant
ABBOTT VASCULAR
3200 lakeside drive
santa clara, CA 95054
PMA NumberP040012
Supplement NumberS003
Date Received12/22/2005
Decision Date03/16/2006
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL OF MODIFICATIONS TO THE PROTOCOL FOR THE ARCHER LONG TERM FOLLOW-UP (LTFU) TRIAL. THE REVISED PROTOCOL INCLUDES MEASURES DESIGNED TO ASSIST IN THE RECRUITMENT AND EVALUATION OF PATIENTS, AND COMPLIES WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE AUGUST 30, 2004 APPROVAL ORDER FOR P040012.
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