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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.
Classification Namefiller, bone void, non-osteoinduction
Generic Namecollagen/hydroxyapatite bone graft substitute
ApplicantNEU COLL
PMA NumberP900039
Supplement NumberS011
Date Received09/19/2001
Decision Date07/02/2002
Product Code
MBS[ Registered Establishments with MBS ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for addition manufacturing sites located at: bioserv corporation, san diego, california; biological test center, b. Braun medical, inc. , irvine, california; neucoll, inc. , cambell, california; and pharmaceutical systems, inc. , mundalein, illinois.