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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) Flour, Avitene Microfibrillar Collagen Hemostat (MCH) SyringeAvitene, and
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 NumberS034
Date Received08/03/2020
Decision Date04/01/2022
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the replacement of current qualitative in process heavy metals testing with a quantitative test and removal of in process testing of total ash content
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