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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 ABSORBABLE HEMOSTAT
Generic NameAgent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantDavol, Inc.
100 Crossings Blvd.
Warwick, RI 02886
PMA NumberP050038
Supplement NumberS030
Date Received06/17/2016
Decision Date12/12/2016
Product Code LMG 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the removal of neurological exclusions from the Indications For Use and changes to the labeling.
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