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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 HEMOSTATS
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantANGIOTECH MEDICAL DEVICE TECHNOLOGIES
3600 S.W 47TH AVENUE
GAINESVILLE, FL 32608
PMA NumberP990030
Supplement NumberS003
Date Received12/27/2001
Decision Date03/14/2002
Withdrawal Date 03/07/2012
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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.
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