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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.
 
DeviceCORDIS CHECKMATE(TM) SYSTEM
Generic NameIntravascular radiation delivery system
ApplicantCordis Corp.
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP990036
Supplement NumberS002
Date Received06/28/2001
Decision Date07/27/2001
Withdrawal Date11/15/2007
Product Code MOU 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE MANUFACTURING PROCESSING AND COLORANT OF THE UNI-DUMMY RIBBON ASSEMBLY TO THE CHECKMATE SYSTEM.
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