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. |
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Device | CORDIS CHECKMATE SYSTEM |
Generic Name | Intravascular radiation delivery system |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. MIAMI LAKES, FL 33014 |
PMA Number | P990036 |
Supplement Number | S001 |
Date Received | 02/13/2001 |
Decision Date | 06/13/2002 |
Withdrawal Date
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11/15/2007 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
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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