Atlas FDA

DRIVER MX2 CORONARY STENT SYSTEM

FDA premarket approval P030009/S001 · decided 2004-08-04

Approval details

PMA number
P030009
Supplement
S001
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
DRIVER MX2 CORONARY STENT SYSTEM
Generic name
STENT, CORONARY
Applicant
Medtronic, Ireland
Date received
2004-02-05
Decision date
2004-08-04
Days to decision
181 days
Decision code
APPR
Product code
MAF
Advisory committee
Cardiovascular
Expedited review
No
Location
Galway
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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