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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameVITAGEL SURGICAL HEMOSTAT
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agent and dressing
Regulation Number878.4490
ApplicantANGIOTECH MEDICAL DEVICE TECHNOLOGIES
PMA NumberP990030
Date Received06/07/1999
Decision Date06/13/2000
Withdrawal Date 03/07/2012
Product Code
LMF[ Registered Establishments with LMF ]
Docket Number 00M-1368
Notice Date 07/12/2000
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S003 S004 S005 
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