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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 ZETA CORONARY STENT SYSTEMS (CSS)
Classification Namestent, coronary
Generic Namecoronary stent system
ApplicantABBOTT VASCULAR INC.
PMA NumberP970020
Supplement NumberS056
Date Received06/24/2010
Decision Date07/20/2010
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Increase in the minimum seal length requirement for the manufacturing of the stent delivery system.
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