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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCORDIS CHECKMATE(TM) SYSTEM
Generic NameIntravascular radiation delivery system
ApplicantCORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES, FL 33014
PMA NumberP990036
Date Received07/01/1999
Decision Date11/03/2000
Withdrawal Date 11/15/2007
Product Code MOU 
Docket Number 00M-1650
Notice Date 12/13/2000
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE CORDIS CHECKMATE(TM) SYSTEM. THE DEVICE IS INDICATED FOR THE DELIVERY OF THERAPEUTIC DOSES OF GAMMA RADIATION FOR THE PURPOSE OF REDUCING IN-STENT RESTENOSIS. THE SYSTEM IS FOR USE IN 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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S003 S002 
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