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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCOLLAGRAFT(TM) BONE GRAFT SUBSTITUTE
Generic NameFiller, bone void, non-osteoinduction
ApplicantNeucoll, Inc.
105 Cooper Ct.
Los Gatos, CA 95032-7604
PMA NumberP900039
Date Received05/25/1990
Decision Date05/28/1993
Reclassified Date06/02/2003
Product Code MBS 
Docket Number 93M-0210
Notice Date 07/22/1993
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Supplements:  S001 S002 S003 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S015 
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