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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.
 
DeviceArista AH; Arista AH Absorbable Hemostat
Generic NameAgent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantDavol, Inc.
100 Crossings Blvd.
Warwick, RI 02886
PMA NumberP050038
Supplement NumberS032
Date Received08/01/2018
Decision Date01/24/2019
Product Code LMG 
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a new supplier of the subcomponent raw material HST (hydrolyzed starch technology) which is used in the manufacturing of the DSM-A (non-sterile powder) component of the Arista™ AH device. Additionally, the supplement includes an improvement in the test method for hydrolyzed starch characterization.
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