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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.
 
DeviceVITAGEL RT3 SURGICAL HEMOSTAT
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantSTRYKER CORP.
2825 AIRVIEW BOULEVARD
PORTAGE, MI 49002
PMA NumberP050044
Supplement NumberS025
Date Received10/22/2013
Decision Date11/15/2013
Withdrawal Date 07/10/2019
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR A DEVICE NAME CHANGE FOR THE VITAGEL RT SURGICAL HEMOSTAT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITAGEL RT3 SURGICAL HEMOSTAT WITH NO CHANGE IN THE INDICATIONS FOR USE.
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