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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.
 
DeviceVISION AND MINVISION CORONARY STENT SYSTEMS
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
ABBOTT VASCULAR
p.o. box 9018
temecula, CA 92589-9018
PMA NumberP020047
Supplement NumberS037
Date Received07/18/2011
Decision Date08/10/2011
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to a component in-process inspection.
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