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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVISION AND ML8 CORONARY STENT SYSTEMS
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
ABBOTT VASCULAR
p.o. box 9018
temecula, CA 92589-9018
PMA NumberP020047
Supplement NumberS052
Date Received10/02/2012
Decision Date11/02/2012
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 SAMPLING FOR PYROGEN TESTING.
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