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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 FLEXITIP/FLEXITIP XL/FLEXITIP XL-R
Generic NameAgent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantDavol, Inc.
100 Crossings Blvd.
Warwick, RI 02886
PMA NumberP050038
Supplement NumberS027
Date Received11/02/2015
Decision Date12/02/2015
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGES TO THE POLY/TYVEK POUCH PACKAGING USED IN BOTH ARISTA FLEXITIP XL AND FLEXITIP XL-R. THESE CHANGES INCLUDED 1) REVISION TO POUCH SEALING PARAMETERS 2) ADDITION OF APPEARANCE CRITERIA AND REVISED TOLERANCES TO MANUFACTURED POUCH, AND 3) IMPLEMENTATION OF A NEW SEALER FOR THE FLEXITIP XL POUCH.
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