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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 NameMULTI-LINK MINI VISION CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecoronary stent
ApplicantGUIDANT CORPORATION
PMA NumberP020047
Supplement NumberS003
Date Received04/12/2004
Decision Date09/10/2004
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the new product line, the multi-link mini vision coronary stent system. The device is indicated for improving coronary luminal diameter in patients with abrupt or threatened abrupt closure with failed interventional therapy of de novo and restenotic native coronary artery lesions (length <=25 mm) with reference vessel diameters from 2. 0 to 2. 5 mm.
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