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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 MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FOUR FAMILY
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agents, collagen based
Regulation Number878.4490
ApplicantDAVOL INC., SUB. C.R. BARD, INC.
PMA NumberN17600
Supplement NumberS023
Date Received09/08/2005
Decision Date10/06/2005
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing process changes for the avitene microfibrillar collagen hemostat (mch) families of devices.
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