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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAVITENE ULTRA FOAM CAST MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) SPONGE
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantDAVOL, INC., SUB. C.R. BARD, INC.
100 Crossings Boulevard
Warwick, RI 02886
PMA NumberN17600
Supplement NumberS017
Date Received12/14/2000
Decision Date07/11/2001
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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