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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 OVER-THE-WIRE CORONARY STENT SYSTEM AND MICRO-DRIVER MX2 CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP030009
Supplement NumberS002
Date Received07/14/2004
Decision Date04/21/2006
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the micro-driver over-the-wire coronary stent system and the micro-driver mx2 coronary stent system. The systems are 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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