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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 Blvd.
Warwick, RI 02886
PMA NumberN17600
Supplement NumberS030
Date Received06/28/2018
Decision Date08/01/2018
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Alternate in-process test method and test equipment (digital meter) used for % Ethanol determination during AviteneTM Microfibrillar Collagen Hemostat bulk flour production.
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