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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 ABSORRBABLE HEMOSTAT
Classification Nameagent, absorbable hemostatic, non-collagen based
Generic Nameagent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
Applicant
C.R. Bard, Inc.
160 new boston street
woburn, MA 01801
PMA NumberP050038
Supplement NumberS019
Date Received12/13/2013
Decision Date02/27/2014
Product Code
LMG[ Registered Establishments with LMG ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A LARGER (18 GRAM) BELLOW CONTAINER FOR THE 5 GRAM ARISTA AH DEVICE AND INCREASES IN THE DIMENSIONS OF THE DEVICE PACKAGING, SPECIFICALLY, THE FOIL AND TYVEK POUCHES AND SHELF AND SHIPPER BOXES.
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