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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 NumberS012
Date Received12/10/2012
Decision Date01/09/2013
Product Code
LMG[ Registered Establishments with LMG ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in short term storage conditions in the powder filler for relative humidity controls and the addition of 100% weight inspection post filling.
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