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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 MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH)
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 NumberS016
Date Received12/21/1998
Decision Date02/28/2000
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to market a product line extension.
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