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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
ApplicantBoston Scientific Scimed, Inc.
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP970061
Supplement NumberS007
Date Received04/20/1999
Decision Date09/17/1999
Withdrawal Date07/17/2007
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of a centerless grinding process to widen trace element nitinol tubing material.
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