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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
Classification Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantORTHOVITA, INC.
PMA NumberP050044
Supplement NumberS001
Date Received08/08/2006
Decision Date01/25/2007
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised cellpaker manufacture by special team medical services (yorba linda, california), terminal sterilization of the cellpaker by sterigenics us, inc. (san diego, california), and change in contractor performing the limulus amebocyte lysate assay to lexamed, ltd (toledo, ohio).
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