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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 NameDRIVER MX2 CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP030009
Supplement NumberS001
Date Received02/05/2004
Decision Date08/04/2004
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order 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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