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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameAVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT)
Classification Nameagent, absorbable hemostatic, collagen based
Generic Namehemostatic agent
Regulation Number878.4490
ApplicantDAVOL, INC., SUB. C.R. BARD, INC.
PMA NumberN17600
Date Received05/17/1974
Decision Date08/26/1976
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S023 S024 S025 S026 S027 S028 S029 
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