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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.
Classification Namestent, coronary
Generic Namestent, coronary
parkmore business park west
PMA NumberP030009
Supplement NumberS020
Date Received03/31/2008
Decision Date10/22/2008
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the micro-driver rapid exchange delivery platformand the addition of the medtronic mexico facility in tijuana for the manufacturing of cathetersub-assemblies. The device, as modified, will be marketed under the trade name micro-driverrapid exchange (rx) coronary stent system and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions with reference vessel diameters of 2. 25 - 2. 75 mm and <= 21 mm in length. Outcome beyond 270 days for this permanent implant is unknown at present.