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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.
 
DeviceRADIUS CORONARY STENT WITH SINGLE-OPERATOR EXCHANGE (SOE) DELIVERY SYSTEM
Generic NameSTENT, CORONARY
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
One Scimed Place
Maple Grove, MN 55311
PMA NumberP970061
Supplement NumberS012
Date Received10/09/2001
Decision Date11/29/2001
Withdrawal Date 07/17/2007
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC IRELAND, LTD, GALWAY, IRELAND AND AN ADDITIONAL STERILIZATION FACILITY LOCATED AT ISOTRON, OFFALY, IRELAND.
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