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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 RT3 SUTGICAL HEMOSTAT
Classification Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantSTRYKER CORP.
PMA NumberP050044
Date Received11/30/2005
Decision Date06/16/2006
Product Code
LMF[ Registered Establishments with LMF ]
Docket Number 06M-0293
Notice Date 07/26/2006
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH 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 Order Approval Order
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 
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