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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 RX, VISION OTW MINI VISION RX, MINI VISION OTW
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
ABBOTT VASCULAR
p.o. box 9018
temecula, CA 92589-9018
PMA NumberP020047
Supplement NumberS043
Date Received02/06/2012
Decision Date03/07/2012
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE TO THE BALLOON MANUFACTURING PROCESS.
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