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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameagent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantC.R. BARD, INC.
PMA NumberP050038
Supplement NumberS023
Date Received07/29/2014
Decision Date03/16/2015
Product Code
LMG[ Registered Establishments with LMG ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the line extension of the flexitip xl applicator family to include the flexitip xl-r applicator. The modification is based upon the current applicator design but now includes an additional outer stainless steel tubing to create a rigid (xl-r) portion of the applicator tip. In addition, approval for revision of the instructions for use of the arista ah product labeling in order to inform users of use of the new applicator during endoscopic/ laparoscopic uses.