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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 NumberS001
Date Received02/13/2001
Decision Date06/13/2002
Withdrawal Date11/15/2007
Product Code MOU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE EXISTING RADIATION DOSIMETRY PROTOCOL FROM A PROTOCOL THAT IS BASED ON INTRAVASCULAR ULTRASOUND (IVUS) TO A PROTOCOL THAT PRESCRIBES A FIXED DOSE OF 14 GY AT A DISTANCE OF 2 MM FROM THE CENTERLINE OF THE SOURCE AND IS INDICATED FOR THE TREATMENT OF NATIVE CORONARY ARTERIES (2.75 - 4.0 MM IN DIAMETER AND LESIONS UP TO AND INCLUDING 45 MM IN LENGTH) WITH IN-STENT RESTENOSIS FOLLOWING PERCUTANEOUS REVASCULARIZATION USING CURRENT INTERVENTIONAL TECHNIQUES.
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