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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 NameNEUGRAFT
Classification Namefiller, bone void, non-osteoinduction
Generic Namecollagen/hydroxyapatite bone graft substitute
ApplicantNEUCOLL, INC.
PMA NumberP900039
Supplement NumberS013
Date Received04/30/2004
Decision Date06/07/2004
Product Code
MBS[ Registered Establishments with MBS ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
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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