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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 NumberS005
Date Received05/19/2008
Decision Date05/30/2008
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval to change the vendor of the 1 liter and 5 liter media bags used to store intermediae solutions during vitagel aseptic processing.
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