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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 ULTRA WRAP COLLAGEN HEMOSTAT
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agents, collagen based
Regulation Number878.4490
ApplicantDAVOL INC., SUB. C.R. BARD, INC.
PMA NumberN17600
Supplement NumberS019
Date Received10/18/2001
Decision Date12/06/2001
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for manufacturing modifications to the avitene ultrafoam cast microfibrillar collagen hemostat (mch) sponge and modifications to the labeling. The device, as modified, will be marketed under the trade name avitene ultrawrap collagen hemostat and is indicated for use in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
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