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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameARISTA AH ABSORBABLE HEMOSTAT
Classification Nameagent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantMEDAFOR, INC.
PMA NumberP050038
Date Received09/30/2005
Decision Date09/26/2006
Product Code
LMG[ Registered Establishments with LMG ]
Docket Number 06M-0396
Notice Date 10/03/2006
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the arista ah absorbable hemostat. The device is indicated for use in surgical procedures (except neurological, ophthalmic, and urological) as an adjunctive hemostatic device to assist when control of capillary, venous, and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S011 
S012 S013 S015 S016 S017 S018 S019 S020 S021 
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