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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 NumberS013
Date Received06/11/2003
Decision Date07/11/2003
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change the procedure for recording temperatures during the dry heat sterilization process of the avitene products.
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