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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 SURGICAL HEMOSTAT (VITAGEL)
Classification Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantSTRYKER CORP.
PMA NumberP050044
Supplement NumberS026
Date Received11/14/2013
Decision Date02/11/2014
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes to the vitaprep plasma separator component of vitagel surgical hemostat: addition of hydrafoam and silicone o-ring inserts to the inside of the cap, increase in the length of the plunger stopper support, remolding of the cap, and update in the primary packaging.
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