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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 NameCOLLAGRAFT STRIP BONE GRAFT MATRIX
Classification Namefiller, bone void, non-osteoinduction
Generic Namecollagen/hydroxyapatite bone graft substitute
ApplicantNEU COLL
PMA NumberP900039
Supplement NumberS010
Date Received11/23/1998
Decision Date12/07/1998
Product Code
MBS[ Registered Establishments with MBS ]
Advisory Committee Physical Medicine
Supplement Typereal-time process
Supplement Reason process change: manufacturing
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.
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