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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 NameVITAPREP PLASMA SEPERATOR
Classification Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantSTRYKER CORP.
PMA NumberP050044
Supplement NumberS023
Date Received08/29/2012
Decision Date09/25/2012
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the following two changes to the labeling instructions for use for the vitaprep plasma separator: 1) inclusion of warning statement: "always wear well fitting gloves when handling vitaprep¿ and 2) inclusion of instructions: "assure there is no blood in the luer connection. If blood is present, carefully clear the area of residual blood. ¿.
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