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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, collagen based
Generic Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
235 east 42nd st.
new york, NY 10017
PMA NumberN18286
Supplement NumberS012
Date Received12/08/1999
Decision Date10/16/2000
Product Code
LMF[ Registered Establishments with LMF ]
Docket Number 00M-1616
Notice Date 11/15/2000
Advisory Committee General & Plastic Surgery
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of bone hemostasis to the indications for use.