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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 NameMICRO-DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC IRELAND
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: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the micro-driver rapid exchange delivery platform and the addition of the medtronic mexico facility in tijuana for the manufacturing of catheter sub-assemblies. The device, as modified, will be marketed under the trade name micro-driver rapid 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.
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