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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.
 
DeviceAVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT)
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantDAVOL, INC., SUB. C.R. BARD, INC.
100 Crossings Boulevard
Warwick, RI 02886
PMA NumberN17600
Date Received05/17/1974
Decision Date08/26/1976
Product Code LMF 
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
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 S030 S031 S032 S033 S034 S035 S037 S038 
S039 
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