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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.
 
DeviceAVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY/FLOUR & ULTRAFOAM CAST SPONGE/(MCH) ULTRAWRAP/(MCH0 SYRINGEAVITENE
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
Applicant
DAVOL, INC., SUB. C.R. BARD, INC.
100 crossings boulevard
warwick, RI 02886
PMA NumberN17600
Supplement NumberS025
Date Received09/02/2011
Decision Date09/29/2011
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to quality control testing for incoming raw material (bovine corium) and modification to finished goods testing.
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