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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) Non-Woven Web and EndoAvitene
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantC.R. Bard, Inc.
160 New Boston St.
Woburn, MA 01801
PMA NumberP800002
Supplement NumberS025
Date Received05/20/2019
Decision Date06/21/2019
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  
Change to in-process manufacturing test methods and in process bioburden monitoring specifications of the Avitene bulk flour component prior to sterilization.
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