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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 NON-WOVEN WEB
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantC.R. Bard, Inc.
160 New Boston St.
Woburn, MA 01801
PMA NumberP800002
Supplement NumberS032
Date Received11/12/2024
Decision Date02/18/2025
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for changes made to the Avitene product family’s labeling, including the instructions for use (IFU), during the European Union (EU) Medical Device Regulation (MDR) transition.
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