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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 NameZETA RX/ULTRA RX/OTW
Classification Namestent, coronary
Generic Namecoronary stent system
ApplicantABBOTT VASCULAR INC.
PMA NumberP970020
Supplement NumberS063
Date Received04/14/2011
Decision Date05/12/2011
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 
A manual to an automated process change for packaging labeling inspection.
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