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VASCULAR DRIVER MX2 CORONARY STENT SYSTEM& MIRCODRIVER MX2 CORONARY STENT SYSTEM

FDA premarket approval P030009/S008 · decided 2006-12-08

Approval details

PMA number
P030009
Supplement
S008
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
VASCULAR DRIVER MX2 CORONARY STENT SYSTEM& MIRCODRIVER MX2 CORONARY STENT SYSTEM
Generic name
STENT, CORONARY
Applicant
Medtronic, Ireland
Date received
2006-11-27
Decision date
2006-12-08
Days to decision
11 days
Decision code
APPR
Product code
MAF
Advisory committee
Cardiovascular
Expedited review
No
Location
Galway
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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