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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.
 
DeviceSCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
One Scimed Place
Maple Grove, MN 55311
PMA NumberP970061
Supplement NumberS002
Date Received08/13/1998
Decision Date04/21/1999
Withdrawal Date 07/17/2007
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Proposal for 5 year post-approval study protocol.
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