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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOSTASIS(R)/DYNASTAT SURGICAL HEMOSTAT
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantAngiotech Medical Device Technologies
3600 S.W 47th Ave.
Gainesville, FL 32608
PMA NumberP990030
Supplement NumberS001
Date Received10/18/2000
Decision Date01/02/2001
Withdrawal Date03/07/2012
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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