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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.
 
DeviceDRIVER MX2 CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantMEDTRONIC IRELAND
Parkmore Business Park West
Galway 
PMA NumberP030009
Supplement NumberS001
Date Received02/05/2004
Decision Date08/04/2004
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDING THE MX2 CATHETER TO THIS PRODUCT LINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DRIVER MX2 CORONARY STENT SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS WITH REFERENCE VESSEL DIAMETERS OF 3.0 - 4.0 MM AND <=30 MM IN LENGTH USING DIRECT STENTING OR PRE-DILATATION. OUTCOME BEYOND 270 DAYS FROM THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.
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