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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/31MM RADIUS OTW & 31 MM RADIUS SOE
ApplicantBoston Scientific Scimed, Inc.
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP970061
Supplement NumberS006
Date Received11/23/1998
Decision Date06/30/1999
Withdrawal Date07/17/2007
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the 31 mm SCIMED(R) RADIUS(TM) Coronary Stent with Over-The-Wire (OTW) and Single-Operator (SOE) Delivery Systems.
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