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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 Namefiller, bone void, non-osteoinduction
105 cooper ct.
los gatos, CA 95032-7604
PMA NumberP900039
Supplement NumberS011
Date Received09/19/2001
Decision Date07/02/2002
Product Code
MBS[ Registered Establishments with MBS ]
Advisory Committee Orthopedic
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.