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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 NumberS012
Date Received09/12/2002
Decision Date10/10/2002
Reclassified Date06/02/2003
Product Code MBS 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE DEFINITION OF A SAMPLE ITEM PORTION (SIP) FROM A STRIP ALONE TO A STRIP PLUS INNER PACKAGING (INNER TRAY, INNER TRAY LID, LIFT TAB, AND TRAY RETAINER). ONLY A SINGLE SIP MAY BE SOURCED FROM EACH TRAY.
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