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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
ApplicantMEDICAL DEVICE TECHNOLOGIES, INC.
PMA NumberP900039
Supplement NumberS015
Date Received12/27/2004
Decision Date01/24/2005
Product Code
MBS[ Registered Establishments with MBS ]
Advisory Committee Physical Medicine
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the final product testing from rabbit pyrogenicity test to a limulus amebocyte lysate (lal) gel-clot test for determining the presence of endotoxins.
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