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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 FOAM CAST MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) SPONGE
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 NumberS017
Date Received12/14/2000
Decision Date07/11/2001
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the slurry preparation and lyophilization process and adjustments to the product specifications resulting from these manufacturing changes.
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