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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameintravascular radiation delivery system
Generic Nameintravascular radiation delivery system
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[ Registered Establishments with MOU ]
Docket Number 00M-1650
Notice Date 12/13/2000
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003