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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.
 
Trade NameARISTA AH ABSORBABLE HEMOSTAT
Classification Nameagent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantMEDAFOR, INC.
PMA NumberP050038
Supplement NumberS007
Date Received06/17/2008
Decision Date07/02/2008
Product Code
LMG[ Registered Establishments with LMG ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a new trade name. The device, as modified, will be marketed under the trade name vitasure and is indicated for use in surgical procedures (except neurological and ophthalmic) as an adjunctive hemostatic device to assist when control of capillary, venous, and arterial bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.
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