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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 NameAVITENE MICROFIBBRILLAR COLLAGEN HEMOSTAT PRODUCTS- NON-WOVEN WEB, ULTRAFOAM, FLOUR 1 G SYRINGE, ENDO AVITENE
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agents, collagen based
Regulation Number878.4490
ApplicantC.R. BARD, INC.
PMA NumberN17600
Supplement NumberS029
Date Received05/30/2014
Decision Date06/26/2014
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Foil pouch supplier facility site change and the proposed removal of a rejection criterion for component acceptance in an in-process inspection step for the avitene product family.
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