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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 FAMILY OF CORONARY STENT SYSTEMS
Classification Namestent, coronary
Generic Namecoronary stent system
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
PMA NumberP970020
Supplement NumberS033
Date Received05/07/2001
Decision Date06/01/2001
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a replacement white foil marker material on the following family of coronary stent systems: multi-link tet, multi-link ultr, multi-link penta and multi-link pix (currently under review).
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