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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.
 
DeviceNEUGRAFT
Generic NameFiller, bone void, non-osteoinduction
ApplicantNEUCOLL, INC.
105 COOPER CT.
LOS GATOS, CA 95032-7604
PMA NumberP900039
Supplement NumberS013
Date Received04/30/2004
Decision Date06/07/2004
Reclassified Date 06/02/2003
Product Code MBS 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE PRODUCT "NEUGRAFT". COLLAGRAFT STRIP BONE GRAFT MATRIX (COLLAGRAFT) WAS ORIGINALLY APPROVED BY THE FDA ON JANUARY 27, 1994 (REVIEW OF P900039). THE PRODUCT CURRENTLY CONTINUES TO BE MARKETED BY THAT NAME. NEUGRAFT IS IDENTICAL TO COLLAGRAFT STRIP BONE GRAFT MATRIX, EXCEPT THAT THE BRAND NAME ON THE LABELING IS DIFFERENT. THE LABELING FOR NEUGRAFT INDICATED AND EXPLAINS THAT THE TWO PRODUCTS ARE THE SAME, BUT ARE SOLD THROUGH DIFFERENT DISTRIBUTION CHANNELS. AS PROPOSED, THE PRODUCT WILL CONTINUE TO BE SOLD USING BOTH NAMES COLLAGRAFT AND NEUGRAFT. THERE WILL BE NO CHANGE AFFECTING SAFETY AND EFFECTIVENESS FOR THIS PRODUCT.
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