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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOLLAGRAFT(TM) BONE GRAFT MATRIX
Generic NameFiller, bone void, non-osteoinduction
ApplicantNeucoll, Inc.
105 Cooper Ct.
Los Gatos, CA 95032
PMA NumberP900039
Supplement NumberS007
Date Received01/24/1995
Decision Date02/14/1995
Reclassified Date06/02/2003
Product Code MBS 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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