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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
Generic NameFiller, bone void, non-osteoinduction
ApplicantNeucoll, Inc.
105 Cooper Ct.
Los Gatos, CA 95032
PMA NumberP900039
Supplement NumberS011
Date Received09/19/2001
Decision Date07/02/2002
Reclassified Date06/02/2003
Product Code MBS 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDITION MANUFACTURING SITES LOCATED AT: BIOSERV CORPORATION, SAN DIEGO, CALIFORNIA; BIOLOGICAL TEST CENTER, B. BRAUN MEDICAL, INC., IRVINE, CALIFORNIA; NEUCOLL, INC., CAMBELL, CALIFORNIA; AND PHARMACEUTICAL SYSTEMS, INC., MUNDALEIN, ILLINOIS.
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