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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 PARTICLES
Generic NameAgent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantDavol, Inc.
100 Crossings Boulevard
Warwick, RI 02886
PMA NumberP050038
Supplement NumberS015
Date Received02/22/2013
Decision Date03/21/2013
Product Code LMG 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
PROPOSED INTRODUCTION OF AN ADDITIONAL QUALITY CONTROL STEP FOR THE ARISTA AH ABSORBABLE HEMOSTAT, FLEXITIP APPLICATOR FAMILY.
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