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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
Classification Nameagent, absorbable hemostatic, collagen based
Generic Namenon woven web hemostatic agent
Regulation Number878.4490
ApplicantDAVOL, INC.
PMA NumberP800002
Supplement NumberS014
Date Received10/04/2004
Decision Date10/29/2004
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Elimination and modification of the endotoxin testing and modification of the lit seal strength testing and modification of the foil pouch seal strength testing.
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