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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 Nameabsorbable hemostatic agent and dressing
Regulation Number878.4490
PMA NumberP990030
Supplement NumberS003
Date Received12/27/2001
Decision Date03/14/2002
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the urological exclusion from the "indications for use" statement. The device, as modified, will be marketed under the trade names costasis/dynastat surgical hemostat and is indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to the hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.