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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.
 
DeviceSCIMEN RADIUS STENT WITH MONORAIL DELIVERY SYSTEM
Generic NameSTENT, CORONARY
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
One Scimed Place
Maple Grove, MN 55311
PMA NumberP970061
Supplement NumberS014
Date Received01/08/2002
Decision Date02/15/2002
Withdrawal Date 07/17/2007
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MINOR LABELING CHANGES TO THE PACKAGE LABELING AND THE "DIRECTIONS FOR USE" MANUAL FOR THE RADIUS CORONARY STENT SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SCIMED RADIUS STENT WITH MONORAIL DELIVERY SYSTEM AND IS INDICATED FOR USE IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO NATIVE CORONARY ARTERY AND SAPHENOUS VEIN BYPASS GRAFT LESIONS (LENGTH < 30 MM) WITH A REFERENCE VESSEL DIAMETER RANGING FROM 2.75 TO 4.25 MM AND IS INTENDED TO IMPROVE CORONARY LUMINAL DIAMETER.
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