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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceVITAGEL SURGICAL HEMOSTAT
Classification Nameabsorbable collagen hemostatic agent with thrombin
Generic Nameabsorbable collagen hemostatic agent with thrombin
Regulation Number878.4490
Applicant
ANGIOTECH MEDICAL DEVICE TECHNOLOGIES
3600 s.w 47th avenue
gainesville, FL 32608
PMA NumberP990030
Date Received06/07/1999
Decision Date06/13/2000
Withdrawal Date 03/07/2012
Product Code
PMX[ Registered Establishments with PMX ]
Docket Number 00M-1368
Notice Date 07/12/2000
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR COSTASIS(R) SURGICAL HEMOSTAT AND DYNASTAT(TM) SURGICAL HEMOSTAT. THIS DEVICE IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL, OPHTHALMIC, AND UROLOGICAL) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 
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