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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 DELIVERY SYSTEM
ApplicantBoston Scientific Scimed, Inc.
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP970061
Supplement NumberS008
Date Received01/24/2000
Decision Date02/11/2000
Withdrawal Date07/17/2007
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the addition of two tensile strenght specifications for the pullwire assembly.
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