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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) FAMILY/FLOUR & ULTRAFOAM CAST SPONGE/(MCH) ULTRAWRAP/(MCH0 SYRINGEAVITENE
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agents, collagen based
Regulation Number878.4490
ApplicantDAVOL, INC.
PMA NumberN17600
Supplement NumberS025
Date Received09/02/2011
Decision Date09/29/2011
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 
Changes to quality control testing for incoming raw material (bovine corium) and modification to finished goods testing.
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