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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 CORONARY STENT SYSTEMS
Classification Namestent, coronary
Generic Namecoronary stent system
ApplicantGUIDANT CORP.
PMA NumberP970020
Supplement NumberS046
Date Received02/14/2005
Decision Date04/21/2005
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to update the ifu to revise the mri statement.
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