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Device | VASCULAR DRIVER MX2 CORONARY STENT SYSTEM& MIRCODRIVER MX2 CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P030009 |
Supplement Number | S008 |
Date Received | 11/27/2006 |
Decision Date | 12/08/2006 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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. |