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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.
 
DeviceVASCULAR DRIVER MX2 CORONARY STENT SYSTEM& MIRCODRIVER MX2 CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP030009
Supplement NumberS008
Date Received11/27/2006
Decision Date12/08/2006
Withdrawal Date04/02/2026
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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