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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/DYNASTAT SURGICAL HEMOSTAT
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantANGIOTECH MEDICAL DEVICE TECHNOLOGIES
3600 S.W 47TH AVENUE
GAINESVILLE, FL 32608
PMA NumberP990030
Supplement NumberS002
Date Received11/20/2001
Decision Date12/21/2001
Withdrawal Date 03/07/2012
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE COSTASIS(R)/DYNASTAT(TM) SURGICAL HEMOSTATS' PRODUCT LABELING.
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