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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(TM) 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 NumberS008
Date Received07/28/1995
Decision Date10/30/1995
Product Code
MBS[ Registered Establishments with MBS ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MODIFICATIONS OT THE PRODUCT LABELING PERTAINING TO POLYMYOSITIS(PM)/DERMATOMYOSITIS(DM)
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