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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.
 
DeviceNEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTEM
Generic NameSTENT, CAROTID
ApplicantBOSTON SCIENTIFIC
ONE SCIMED PLACE
MS A350
MAPLE GROVE, MN 55311-1566
PMA NumberP050025
Supplement NumberS007
Date Received12/07/2007
Decision Date12/20/2007
Product Code NIM 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A LABELING CLARIFICATION FOR ?ARRYTHMIA?, THE ADDITION OF ?STENT FRACTURE? TO THE LIST OF POTENTIAL ADVERSE EVENTS, AND CLARIFICATIONS TO THE LABELING TO CLARIFY COMPLETE REMOVAL OF THE DELIVERY SYSTEM TRACKING TIP FROM GUIDE HEATH OR GUIDE CATHETER WHEN REMOVING THE DEVICE UNDER FLUOROSCOPY (ITEMS 11, 12, AND 17 OR TABLE 1).
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