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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 RT3 SUTGICAL HEMOSTAT
Generic NameAbsorbable collagen hemostatic agent with thrombin
Regulation Number878.4490
ApplicantSTRYKER CORP.
2825 AIRVIEW BOULEVARD
PORTAGE, MI 49002
PMA NumberP050044
Date Received11/30/2005
Decision Date06/16/2006
Withdrawal Date 07/10/2019
Product Code PMX 
Docket Number 06M-0293
Notice Date 07/26/2006
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE VITAGEL SURGICAL HEMOSTAT. THE DEVICE IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL AND OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S021 S023 S024 S025 
S026 S027 S028 S029 S030 S031 S032 S033 
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