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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(R)/DYNASTAT SURGICAL HEMOSTAT
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agent and dressing
Regulation Number878.4490
ApplicantCOHESION TECHNOLOGIES, INC.
PMA NumberP990030
Supplement NumberS001
Date Received10/18/2000
Decision Date01/02/2001
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the method of terminal sterilization from e-beam to gamma irradiation and requested an additional 3-ml delivery syringe device with the associated labeling change.
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