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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 RX AND OTW VISION CORONARY STENT SYSTEMS
Classification Namestent, coronary
Generic Namecoronary stent
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
PMA NumberP020047
Supplement NumberS001
Date Received10/02/2003
Decision Date10/08/2003
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a temporary, post-sterile sampling inspection plan for the small (3. 0 mm diameter) multi-link vision coronary stent system.
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