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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.
Classification Namefiller, bone void, non-osteoinduction
Generic Namefiller, bone void, non-osteoinduction
105 cooper ct.
los gatos, CA 95032-7604
PMA NumberP900039
Supplement NumberS010
Date Received11/23/1998
Decision Date12/07/1998
Product Code
MBS[ Registered Establishments with MBS ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to your manufacturing process. These changes involve 1) moving some of the manufacturing operations currently performed in a Class 100 room to a "controlled" environment that provides the equivalent of a Class 10,000 environment, 2) increasing the "hold" time between the remisturization and irradiation processes, and 3) eliminating both the protein concentration assay for past homogenate mixing and the LAL pyrogenicity assay, as described in the supplement.