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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 SURGICAL HEMOSTAT
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantSTRYKER CORP.
2825 AIRVIEW BOULEVARD
PORTAGE, MI 49002
PMA NumberP050044
Supplement NumberS021
Date Received10/27/2011
Decision Date10/11/2013
Withdrawal Date 07/10/2019
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Review MemoReview Memo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A NEW VERSION OF VITAGEL WHERE THE BOVINE THROMBIN COMPONENT IS REPLACED WITH RECOMBINANT HUMAN THROMBIN. THE PRODUCT, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITAGEL RT AND IS INDICATED IN SURGICAL PROCEDURES (OTHER THAN NEUROSURGICAL AND OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
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