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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.
 
DeviceCOLLAGRAFT STRIP BONE GRAFT MATRIX
Classification Namefiller, bone void, non-osteoinduction
Generic Namefiller, bone void, non-osteoinduction
Applicant
NEUCOLL, INC.
105 cooper ct.
los gatos, CA 95032-7604
PMA NumberP900039
Supplement NumberS015
Date Received12/27/2004
Decision Date01/24/2005
Product Code
MBS[ Registered Establishments with MBS ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
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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