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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) NON-WOVEN WEB
Classification Nameagent, absorbable hemostatic, collagen based
Generic Namenon woven web hemostatic agent
Regulation Number878.4490
ApplicantDAVOL, INC.
PMA NumberP800002
Supplement NumberS012
Date Received05/23/2001
Decision Date06/18/2001
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 
Elimination of certain in process or final device tests performed on avitene collagen hemostasis (mch) products. This will eliminate test redundancy, waste and/or provide a more efficient utilization of test samples selected during the processing of avitene.
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