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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 NumberS011
Date Received09/19/2001
Decision Date07/02/2002
Product Code
MBS[ Registered Establishments with MBS ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
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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