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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceARTEGRAFT{TM} AND REINFORCED ARTEGRAFT{TM}
Classification Nametissue graft of 6mm and greater
Generic Nametissue graft of 6mm and greater
Applicant
ARTEGRAFT, INC.
206-208b north center drive
north brunswick, NJ 08902
PMA NumberN16837
Date Received07/01/1979
Decision Date08/01/1979
Product Code
LXA[ Registered Establishments with LXA ]
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S003 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S014 S015 S017 S018 S019 S020 S021 
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