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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 SYSTEM
Generic NameIntravascular radiation delivery system
ApplicantCordis Corp.
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP990036
Supplement NumberS003
Date Received06/10/2002
Decision Date07/25/2002
Withdrawal Date11/15/2007
Product Code MOU 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE REGARDING THE RECOILING OF THE SOURCE RIBBON ON THE SPOOL OF THE DELIVERY DEVICE AND THE USE OF THE METAL CAPS ON THE ENDS OF THE DELIVERY DEVICE.
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