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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameVASCULAR DRIVER MX2 CORONARY STENT SYSTEM& MIRCODRIVER MX2 CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP030009
Supplement NumberS008
Date Received11/27/2006
Decision Date12/08/2006
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a warning, which will inform the physician of the potential vessel wall damage that could occur if fluoroscopy is not used during wire interchange, and an update of the guide wire interchange instructions to ensure that physicians use high quality fluoroscopy to determine guide wire position before advancing into the coronary arteries.
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