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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameVITAGEL RT SURGICAL HEMOSTAT
Classification Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantSTRYKER CORP.
PMA NumberP050044
Supplement NumberS025
Date Received10/22/2013
Decision Date11/15/2013
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product Yes
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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