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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 8 SMALL VESSEL CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecoronary stent
ApplicantABBOTT VASCULAR
PMA NumberP020047
Supplement NumberS022
Date Received07/02/2010
Decision Date08/31/2010
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the 2. 25mm diameter stent size as part of the multi-link 8 coronary stent system. The device, as modified, will be marketed under the trade name multi-link 8 sv coronary stent system and is indicated for 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 of 2. 25mm.
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