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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 NameCOSTASIS SURGICAL HEMOSTAT
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agent and dressing
Regulation Number878.4490
ApplicantCOHESION TECHNOLOGIES, INC.
PMA NumberP990030
Supplement NumberS004
Date Received04/30/2002
Decision Date06/13/2002
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at cohesion technologies, palo alto, california.
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